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MINIRIN contains desmopressin. Desmopressin is similar to the naturally occurring antidiuretic hormone (ADH) and reduces urinary excretion.
MINIRIN is used for:
• Treatment of nocturnal enuresis (night-time bedwetting) in patients from the age of 5 after organic disorders of the urinary organs have been excluded:
- Within an overall therapeutical concept, e.g. in cases of failure of other non-medicinal therapies or with indication of a medicinal therapy.
- Caused by nocturnal ADH deficiency (lack of antidiuretic hormone).
• Increased, at least twice nocturnal urination due to increased night-time urine production (nocturia in connection with nocturnal polyuria) in adults.
• Trauma-induced polyuria (over production of urine) and polydipsia (increased thirst and increased fluid intake) after hypophysectomy (disconnection of the pituitary gland), after surgery in the pituitary gland area or craniocerebral injury.
• Central diabetes insipidus (disease characterized by excretion of large amounts of water due to impaired ADH secretion in the brain; ADH = antidiuretic hormone is a hormone of the pituitary gland that reduces excretion of water).
MINIRIN must not be used:
- if you are allergic to desmopressin acetate or any of the other ingredients of this medicine (listed in section 6)
- if you are suffering from habitual polydipsia (habitually increased fluid intake) or psychogenic polydipsia (mentally caused increased thirst and increased fluid intake)
- if you are suffering from polydipsia and are alcohol-dependent
- if you have a known or suspected cardiac insufficiency
- if you have any other disease requiring treatment with diuretics
- if you have low sodium levels in your blood (hyponatraemia)
- if you have moderate to severe renal insufficiency
- if you have conditions with increased ADH secretion (syndrome of inadequate ADH secretion)
- for treatment of increased night-time urination if you are 65 or older
Excessive fluid intake may lead to retention of water in tissue, in particular in infants under the age of 1 or elderly patients, depending on their general health (please see also section 4 Possible side effects).
Warnings and precautions: Talk to your doctor or pharmacist before taking MINIRIN.
Take special caution with MINIRIN
- When used for primary nocturnal enuresis and nocturia indications, you must limit the fluid intake to a minimum from 1 hour before administration until the next morning (at least 8 hours after administration).Treatment without concomitant reduction of fluid intake may lead to water retention and/or mineral metabolism disorder with or without accompanying warning signs and symptoms such as headache, nausea/vomiting,weight gain and, in severe cases cerebral oedema sometimes associated with convulsions and/or clouding of consciousness up to loss of consciousness.
- All patients, in case of children their parents and, where applicable, responsible nursing staff should be carefully instructed to adhere to the fluid restrictions.
- You should use desmopressin with caution if you have a mild renal insufficiency.
- Severe bladder dysfunction and outlet obstruction should be precluded before starting treatment with MINIRIN.
- Elderly patients and patients with low sodium levels in the blood have an increased risk of developing highly reduced sodium levels (hyponatraemia).
- If you develop a disease which could affect fluid and/or mineral metabolism, e.g. diseases with fever or diarrhoea, your doctor might stop treatment with MINIRIN.
- If you are at risk for increased intracranial pressure.
- You should adhere to fluid restrictions to prevent strongly decreased sodium levels in the blood. Additionally, your doctor should determine your sodium levels in the blood more frequently, if you take medicinal products which induce SIADH (see section Other medicines and MINIRIN) or if you take medicinal products for rheumatic diseases.
Other medicines and MINIRIN
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. If you take medicinal products which induce SIADH (syndrome of inadequate ADH secretion) like e.g. some medicinal
products for depressions (tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine), medicinal products with the active ingredient carbamazepine for epilepsy and some medicinal products for diabetes (sulfonylurea
group, particularly chlorpropamide) the effect of MINIRIN may be increased. This leads to an increased risk of water retention and lack of sodium in the blood. If you use medicinal products for rheumatic diseases (NSAID=non-steroidal
anti-inflammatory drugs like e.g. indometacin), the inhibitory effect of MINIRIN on water excretion may be intensified. Accompanying treatment with loperamide, a substance used for diarrhoea, may also increase the risk of hyperhydration
of the body. Other medicinal products which slow down the intestinal transport can have the same effect. If used concomitantly with oxytocin (a drug used to stimulate labour pains), an even stronger reduction of water excretion and a
weaker perfusion of the uterus may result. If you use clofibrate (a drug used to lower blood lipid levels), indomethacin (a drug used in rheumatic diseases) or carbamazepine (a drug used, for instance, in epilepsy) concomitantly with
MINIRIN, the inhibitory effect of MINIRIN on water excretion may be increased. Glibenclamide (a drug used to reduce blood sugar levels) may reduce the effect of MINIRIN.
MINIRIN with food and drink: If MINIRIN is taken together with food, the intensity and duration of effect may be reduced.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.If you are pregnant, caution should be exercised. Monitoring of blood pressure is recommended. MINIRIN may be administered to pregnant women after thoroughly weighing up the risks and benefits. Only small amounts of desmopressin pass to the mother’s milk. When administering therapeutic doses of desmopressin, no effects on the newborn/child are to be expected.
Driving and using machines: MINIRIN has no or negligible effect on the ability to drive and operate machinery.
Always take MINIRIN exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. In the event of signs of water retention and/or decreased sodium levels in the blood (headache, fluid accumulation in the tissue, nausea/vomiting, weight gain and, in severe cases, cramps) treatment should be interrupted until you have fully recovered. When restarting treatment, you must strictly restrict fluid supply. In addition, your doctor will closely monitor blood sodium levels.
Special populations:Treatment of elderly patients is not recommended. If, nevertheless, your doctor decides for treatment, your blood sodium levels will be monitored on several days before start of treatment. Melt tablets with a higher
concentration are available for higher and highest doses.
The recommended dose is:
Primary nocturnal enuresis (night-time bedwetting)
For the treatment of night-time bedwetting, an initial dosage of 120 micrograms (2 MINIRIN melt tablets with 60 micrograms or 1 MINIRIN melt tablet with 120 micrograms) before going to bed is recommended. In cases of insufficient therapy success, your doctor may increase the dose to 240 micrograms (2 MINIRIN melt tablets with 120 micrograms or 1 MINIRIN melt tablet with 240 micrograms). You may not increase the dose without your doctor’s approval. Fluid supply should be reduced.The determined effective dose will also be the maintenance dose. It will be determined individually by your doctor and should be used throughout the entire treatment period. Duration of administration: After a treatment period of up to 3 months there should be a treatment-free interval of at least 1 week to check whether healing has taken place or whether therapy should be continued.
Increased night-time voiding (nocturia) due to increased urine production during the night
For treatment of increased night-time urination, the recommended initial dose is 60 micrograms desmopressin (1 MINIRIN melt tablet with 60 micrograms) before going to bed. If this dose is not sufficient after one week, it may be increased up to 120 micrograms (2 MINIRIN melt tablets with 60 micrograms or 1 MINIRIN melt tablet with 120 micrograms) and subsequently to 240 micrograms (2 MINIRIN melt tablets with 120 micrograms or 1 MINIRIN melt tablet with 240 micrograms) by weekly dose escalations. You should reduce nocturnal fluid supply as far as possible (see section 2). Your doctor will discuss with you the measures required before start of treatment. Before start of treatment, you should record the times of urination and the amount of urine for at least 48 hours. In addition, your doctor will measure sodium levels in your blood before start of treatment.You should check your body weight over several days at the beginning of treatment and after each dose increase. If adequate effect is not achieved within 1 week with appropriate dosage, the medication should be discontinued.
Central diabetes insipidus (disease characterized by excretion of large amounts of water due to impaired ADH secretion in the brain) as well as trauma-induced polyuria (overproduction of urine) and polydipsia
(increased thirst and increased fluid intake). Adults and children: the daily dose is normally between 120 micrograms (2 MINIRIN melt tablets with 60 micrograms or 1 MINIRIN melt tablet with 120 micrograms) and 720 micrograms (3 MINIRIN melt tablets with 240 micrograms). Treatment should be started with 60 micrograms 3 times daily (1 MINIRIN melt tablet with 60 micrograms each).
The maintenance dose in most of the patients is 60 – 120 micrograms 3 times daily (1 – 2 MINIRIN melt tablets with 60 micrograms each). Your doctor will individually adapt the dosage to your response to treatment.
Method of administration:MINIRIN is placed under the tongue where it dissolves. Please consult your doctor or pharmacist, if you believe that the effect of MINIRIN is too strong or too weak.
If you take more MINIRIN than you should: Special attention should be given to signs of hyperhydration of the body (water intoxication). It may also occur if there is excessive fluid intake at the same time or shortly after the administration of MINIRIN. It manifests by weight gain, headache, nausea and, in severe cases, convulsions sometimes associated with clouding of consciousness up to loss of consciousness (see also section Side effects). Please consult your doctor if you are not sure.
If you forget to take MINIRIN:In the case of primary nocturnal enuresis and nocturia you should not take the melt tablets too late. Continue taking the medicinal product as usual on the next day.
In the case of central diabetes insipidus you should repeat dosing as soon as you notice the error. Keep to the usual interval until the next dose.
If you stop taking MINIRIN: Treatment should only be interrupted or stopped on advice of your doctor. If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Treatment without simultaneous limited fluid supply can lead to retention of water in the tissue (water retention) / mineral metabolism disorder (hyponatraemia) with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain and, in severe cases, cramps sometimes associated with sleepiness up to prolonged loss of consciousness).
Adults:
Very common (may affect more than 1 of 10 treated patients): headache.
Common (may affect up to 1 of 10 treated patients): decreased blood sodium levels, drowsiness, high blood pressure, nausea, stomach pain, diarrhea, constipation, vomiting, bladder and urethral symptoms, retention of water in the tissue, tiredness.
Uncommon (may affect up to 1 of 100 treated patients): insomnia, somnolence, paraesthesia, visual impairment, dizziness, rapid heartbeats, decrease of blood pressure (orthostatic hypotension),difficulties in breathing, disorders in the upper abdomen (dyspepsia), flatulences, bloating, sweating, itching, rash, itching wheals (hives), muscle cramps, muscle pain, malaise, chest pain, influenza-like illness, weight gain, increase of liver enzymes, decreased blood potassium levels.
Rare (may affect up to 1 of 1000 treated patients): confusional state, allergic-inflammatory skin diseases.
Not known (frequency cannot be estimated from the available data): acute hypersensitivity reaction (anaphylactic reaction), decrease of body water, increased blood sodium levels, seizures, weakness, loss of consciousness (coma).
Children and adolescents:
Common (may affect up to 1 of 10 treated patients): headache.
Uncommon (may affect up to 1 of 100 treated patients): emotional fluctuations, aggressions, stomach pain, nausea, vomiting, diarrhea, bladder and urethral symptoms, swellings of arms and legs because of fluid retention, tiredness.
Rare (may affect up to 1 of 1000 treated patients): anxiety symptoms, nightmares, mood swings, somnolence, high blood pressure, irritability.
Not known (frequency cannot be estimated from the available data): acute hypersensitivity reaction (anaphylactic reaction), decreased blood sodium levels, abnormal behaviour, emotional disorder, depressions, hallucination, insomnia, disturbance in attention, psychomotoric hyperactivity, seizures, nose bleeding, rash, allergic-inflammatory skin diseases, sweating, itching wheals (hives).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children. Do not use this medicinal product after the expiry date printed on the container and the outer carton. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What MINIRIN 60 microgram contains: Active ingredient: Each oral lyophilisate (melt tablet) contains 67 micrograms desmopressin acetate equivalent to 60 micrograms desmopressin.
What MINIRIN 120 micrograms contains: Active ingredient: Each oral lyophilisate (melt tablet) contains 135 micrograms desmopressin acetate equivalent to 120 micrograms desmopressin.
What MINIRIN 240 microgram contains: Active ingredient: Each oral lyophilisate (melt tablet) contains 270 micrograms desmopressin acetate equivalent to 240 micrograms desmopressin.
Other ingredients are: Gelatin, mannitol (Ph.Eur.), citric acid
Manufacturer: Catalent U.K. Swindon Zydis Limited, Frankland Road, Blagrove, SN5 8RU Swindon, Wiltshire, United Kingdom.
Marketing Authorization Holder: FERRING GmbH, Wittland 11, D-24109 Kiel, Germany.
المصنع: كتالينت المملكة المتحدة سويندون زيدس المحدودة, ويلتشاير, اس ان 85 أريو, المملكة المتحدة
مالك حق التسويق: فيرينغ جي ام بي اتش
11,
D-24109 , كييل , المانيا
Treatment of primary nocturnal enuresis;
- within an overall therapeutical concept, e.g. in cases of failure of other non-medicinal
therapies or with indication of a medicinal therapy,
- caused by nocturnal ADH deficiency;
- Symptomatic treatment of nocturia (at least twice a night urine production) in adults, in
connection with nocturnal polyuria.
- Trauma-induced polyuria and polydipsia in the presence of transient lack of ADH after
hypophysectomy, after surgery in the pituitary gland area or cranio-cerebral trauma;
- Central diabetes insipidus
Sublingual use
Primary nocturnal enuresis
For the therapy of nocturnal enuresis, an initial dosage of 120 micrograms desmopressin
before going to bed is recommended. In cases of insufficient therapy success, the dose can
be increased to 240 micrograms. Fluid supply should be reduced.
With symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight
gain and, in severe cases, cramps), the treatment is to be interrupted until the patient has
fully recovered. When continuing treatment, the fluid supply has to be controlled strictly (see
section 4.4 Special warnings and precautions for use).
MINIRIN® is intended for a treatment period of up to 3 months. The necessity of additional
treatment should be verified following interruption of administration for at least one week.
Nocturia with nocturnal polyuria
For treatment of nocturia, the recommended initial dose is 60 micrograms desmopressin at
bedtime. If this dose is not sufficiently effective after one week, it may be increased up to
120 micrograms and subsequently to 240 micrograms by weekly dose escalations.
Reduction of nocturnal fluid supply should be observed (see section 4.4).
In nocturia patients, a frequency/volume chart should be used to diagnose nocturnal polyuria
for at least 48 hours before starting treatment. A night-time urine production exceeding the
functional bladder capacity or 1/3 of the 24-hour urine production is regarded as nocturnal
polyuria.
In addition, serum sodium levels should be measured before start of treatment.
The body weight should be checked over several days at the beginning of treatment and
after increase of dose.
Simultaneous food intake may reduce the intensity and duration of the antidiuretic effect of
low doses of desmopressin (see section 4.5).
Treatment of elderly patients is not recommended. If, nevertheless, therapy is to be
performed, serum sodium levels should be determined before start of treatment, 3 days after
start of treatment, 3 days after a dose increase as well as at other time points deemed
necessary.
In the event of signs of water retention and/or hyponatraemia (headache, oedemas,
nausea/vomiting, weight gain and, in severe cases, cramps), treatment should be interrupted
until the patient has fully recovered. When restarting treatment, strict fluid restriction and close
monitoring of serum sodium levels should be enforced (see section 4.4).
If adequate effect is not achieved within 1 week with appropriate dosage, the medication
should be discontinued.
Central diabetes insipidus
Adults and children: in cases of diabetes insipidus, the dosage is to be adapted individually. The
daily dose is normally between 120 micrograms and 720 micrograms. The initial dosage for
adults and children should be around 60 micrograms, three times daily, and then adapted to the
patient’s individual reaction. The maintenance dose for most patients is 60 – 120 micrograms,
three times daily.
With symptoms of water retention/hyponatraemia, the treatment is to be interrupted, and the
dosage is to be adapted.
Warnings
With treatment of primary nocturnal enuresis and nocturia, the fluid supply is to be reduced to a
minimum from one hour before administration until the next morning (at least 8 hours following
administration). Treatment without simultaneous restriction of fluid supply can lead to water
retention and/or hyponatraemia with or without accompanying warning symptoms (headache,
nausea/vomiting, weight gain) and, in severe cases, to cerebral oedema sometimes associated
with clouding of consciousness up to loss of consciousness.
Precautions for use
Desmopressin should be used with caution in patients with mild renal insufficiency.
Serious bladder function disorders and bladder neck obstruction have to be excluded prior to
treatment.
Elderly patients and those with low sodium serum levels may show an increased risk of
hyponatraemia.
Treatment with desmopressin should be interrupted in cases of upcoming diseases
characterised by fluid and/or electrolyte balance disorders.
Precautions for the avoidance of hyponatraemia have to be taken in cases of:
- accompanying treatment with medicinal products that can induce SIADH, e.g.
antidepressants, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine;
- simultaneous treatment with non-steroidal anti-inflammatory drugs.
Substances known to induce SIADH, e.g. tricyclic antidepressants, selective serotonin
reuptake inhibitors, chlorpromazine, carbamazepine and indomethacine, can increase the
antidiuretic effect which can lead to an increased risk of water retention/hyponatraemia (see
section 4.4).
Non-steroidal anti-inflammatory drugs can induce water retention/hyponatremia (see section
4.4).
Accompanying treatment with loperamide can lead to an increase of the desmopressin
plasma concentration to three times the amount, which, in turn, can cause an increased risk
of water retention/hyponatremia. Although there are no data on this, other medicinal products
which slow down the intestinal transport can have the same effect.
Interactions of desmopressin with substances influencing the liver metabolism are
improbable since desmopressin does not show any significant metabolism in the liver in invitro
studies in human microsomes. In-vivo studies on possible interactions have not been
performed so far.
A standardised diet with 27 % fat significantly reduces the absorption (amount and duration)
of orally administered desmopressin. With respect to the pharmacodynamic characteristics
(urine production or osmolality), no significant effect has been reported. With low
desmopressin doses, simultaneous food supply can reduce the effect and duration of the
antidiuretic effect.
In case of concomitant use of oxytocin, an increased antidiuretic effect and reduced uterus
perfusion should be taken into account.
Clofibrate, indomethacin and carbamazepine may intensify the antiduretic effect of
desmopressin whilst glibenclamide may reduce it.
Pregnancy:
MINIRIN® Melt falls under B of pregnancy categories
The medicinal product should be given with caution to pregnant women and monitoring of
blood pressure is recommended.
The available data with a limited number of pregnant women (n = 53) with diabetes insipidus
show that desmopressin has no negative effect on pregnancy or the health condition of the
fetus or newborn. So far, there are no further relevant epidemiological data. Animal
experiments show no direct or indirect harmful effects on pregnancy, the development of the
embryo or fetus, birth or postnatal development.
MINIRIN® should only be administered to pregnant women after thoroughly weighing up the
risks and benefits.
Lactation:
Examinations of the mother's milk of women who had been administered a high dosage of
300 μg desmopressin (intranasal) showed that the amounts of desmopressin that could be
transferred to the child are too low to influence the diuresis.
None.
Treatment without simultaneous limited fluid supply can lead to water retention/hyponatremia
with or without accompanying warning symptoms (headache, nausea/vomiting, weight gain
and, in serious cases, cramps sometimes associated with somnolence up to prolonged loss
of consciousness). This applies particularly to small children up to one year or elderly people,
dependant on their overall condition.
Primary nocturnal enuresis and central diabetes insipidus
System organ class Common (>1/100, <1/10) Very rare (<1/10,000)
Immune system disorders Allergic reactions of the skin,
general allergic reactions
Metabolic and nutritional
disorders
Hyponatraemia
Psychiatric disorders Emotional disorders
(children)
Nervous system disorders Headache
Gastrointestinal disorders Abdominal pain, nausea
Nocturia
In clinical studies, 35 % of the patients showed side effects during dose titration and 24 %
during long-term treatment. The following table shows the most frequent adverse effects
observed in clinical studies (with 632 patients):
System organ class Very common (>1/10) Common (>1/100, <1/10)
Metabolic and nutritional
disorders
Hyponatraemia
Psychiatric disorders Sleeplessness
Nervous system disorders Headache Dizziness
Vascular disorders Hypertension
Gastrointestinal disorders Nausea, abdominal pain, dry
mouth, diarrhoea
Renal and urinary disorders Pollakisuria
General disorders Tiredness, peripheral
oedema
Investigations Weight gain
For reporting side effect
Kingdom of Saudi Arabia
National Pharmacovigilance Center (NPC)
Fax: 00966112057662
To Contact the executive management of the Pharmacovigilance and crisis
management. Telephone: 9661120382222 00 Ext: 2353-2356-2317-2354-2334-
2340
Free line : 8002490000
Email: npc.drug @ sfda.gov.sa
www.sfda.gov.sa / npc
a) Symptoms of intoxication
The symptoms of an overdose may occur under the following conditions:
- if the dose administered is too high.
- if there is excessive fluid intake at the same time or shortly after desmopressin
administration.
The symptoms are manifested by weight gain (water retention), headaches, nausea and, in
severe cases, water intoxication with convulsions sometimes associated with clouding of
consciousness up to loss of consciousness.
An overdose may occur in particular in infants due to an uncautious drug adjustment.
b) Treatment of intoxication
In case of overdose, depending on its severity, the dose should be reduced, the interval
between single doses should be increased or the drug should be discontinued. Suspected
cerebral oedema requires immediate admittance to intensive care. Convulsions also require
intensive measures. There is no known specific antidote to desmopressin. If diuresis is
indicated, saluretics such as furosemide can be used under monitoring of serum electrolytes.
Pharmacotherapeutic group: Vasopressin and analogues
ATC code: H01B A02
MINIRIN® contain desmopressin, a synthetic analogue to natural human L-argininevasopressin,
and differs formally from the latter by the fact that the amino group of the cystein in
position 1 has been removed and the L-arginine has been replaced by the stereoisomer Darginine.
Because of these alterations, the vasopressoric effect of the molecule is (widely) lost
while the anti-diuretic effect is prolonged..
Desmopressin has an EC50 value of 1.6 pg/ml in relation to the antidiuretic effect. Oral
administration leads to an antidiuretic effect between 6 and 14 hours or more with considerable
inter- and intra-individual variability.
The mean systemic bioavailability of sublingually administered desmopressin like MINIRIN®
in doses of 200, 400 and 800 μg is 0.25% with a 95% confidence interval of 0.21 – 0.31%.
After administration of 200, 400 and 800 μg Cmax was 14, 30 and 65 pg/ml. tmax was observed
0.5 – 2.0 hours after administration. The geometric mean half-life is 2.8 (CV = 24%) hours.
Comparative table of MINIRIN® tablets and MINIRIN® oral lyophilisate:
MINIRIN® tablets MINIRIN® tablets MINIRIN®
oral lyophilisate
MINIRIN®
oral lyophilisate
Desmopressin
acetate
Desmopressin
free base
Desmopressin
free base
Desmopressin
acetate
0.1 mg 89 μg 60 μg approx. 67 μg*
0.2 mg 178 μg 120 μg approx. 135 μg*
0.4 mg 356 μg 240 μg approx. 270 μg*
*) calculated for purposes of comparison
The distribution volume of desmopressin after intravenous injection is 33 l (0.41 l/kg).
Desmopressin does not pass the blood-brain-threshold. Desmopressin shows a moderate to
high inter- and intrapatient variability in bioavailability. Taking desmopressin with food
reduces the amount and the extent of absorption by 40%.
In-vitro preparations of human liver microsomes showed that no significant amount of
desmopressin is metabolised, and a metabolism in the liver in vivo is thus improbable.
After intravenous injection, 45 % of the desmopressin amount is excreted with the urine
within 24 hours.
Preclinical data reveal no special hazard for humans based on conventional studies of repeated
dose toxicity in addition to what is already stated in other parts of this Summary of Product
Characteristics.
Gelatin, mannitol (Ph.Eur.), citric acid
Not applicable
Store at room temperature (do not store above 25 °C). Store in the original package in order to
protect from moisture.
Aluminium/aluminium blister in the following pack sizes:
MINIRIN® 60 micrograms : 10, 30, 90 melt tablets
MINIRIN® 120 micrograms : 10, 30, 90 melt tablets
MINIRIN® 240 micrograms: 10, 30, 90 melt tablets
Not all pack sizes may be marketed.
No special requirements.
