The name of your medicine is Drolina 1mg/ ml Oral Solution (called Drolina in this leaflet). It contains furosemide. This belongs to a group of medicines called diuretics, or water tablets. Furosemide can be used to remove the levels of excess water in the body caused
by heart, lung, kidney, liver or blood vessel problems.

Do not take Drolina
• you are allergic (hypersensitive) to furosemide, sulphonamides or any other ingredients in this liquid (listed in Section 6). The
signs of an allergic reaction include a rash, itching or shortness of breath .
• you have symptoms of weakness, difficulty in breathing and light-headedness. This could be a sign of having too little water in the body.
• you are dehydrated.
• you are not passing water (urine) at all or only a small amount each day.
• you have kidney failure or liver problems, including cirrhosis or liver encephalopathy (confusion, altered levels of consciousness and coma as a result of liver failure).
• you have a severe change in blood salts, such as high potassium or calcium levels or low sodium or magnesium levels. You may notice signs of this such as muscle cramps, weakness and tiredness. You must not take other medicines or supplements that contain potassium.
• you have low blood pressure. The signs of this include dizziness, feeling less alert than usual, fainting and general weakness.
• you have an illness called ‘Addison’s disease’. This is when your adrenal glands are not working properly. It can cause weakness, tiredness, weight loss and low blood pressure you are taking digoxin, used to treat heart problems.
• you are breast-feeding.

Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Drolina.

Warnings and precautions
Talk to your doctor or pharmacist before taking Drolina if:
• you have difficulty in passing water (urine), particularly if you have an enlarged prostate gland.
• you have gout.
• you have low levels of protein in the blood. The signs of this may include swelling, feeling sick (nausea) or being sick (vomiting), diarrhoea and stomach pain.
• you have liver congestion (slowed blood flow through the vessels) or other liver problems you have kidney problems.
• you have brain disorders affecting your nervous system, or a condition called porphyria. This is a disorder that can cause skin blisters, pain in and around the stomach area (abdomen) you have diabetes.
• you are going to give this medicine to a baby that was born too early.
• you have an abnormal heart rhythm or have a history of heart problems you are elderly (above 65), especially if you are taking risperidone for dementia you are pregnant.
• if you are elderly, if you are taking any other medication that can cause a drop in blood pressure or if you have any medical conditions that can cause a drop in blood pressure.

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Drolina.

Having operations and tests whilst on Drolina.
Tell your doctor, dentist or nurse you are taking this medicine if:
• you are going to have an anaesthetic
• you are going to have an X-ray examination that involves taking medicines before the procedure. While you are taking this medicine, your doctor may give you regular blood tests. Your doctor will do this to monitor levels of salts, minerals and glucose in your blood and to check that your kidneys are working properly.

Other Medicines and Drolina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because furosemide, the main ingredient of this medicine, can affect the way some other medicines work. Also some medicines can affect the way furosemide works.

Tell your doctor if you are taking any of these medicines:
• Medicines used to treat high blood pressure known as ACEinhibitors or Angiotensin-II receptor antagonists, such as captopril and losartan or aliskiren or hydralazine .
• medicines used to treat high blood pressure or prostate problems known as alpha-blockers, such as prazosin.
• medicines used to treat high blood pressure and other medicines used to remove water from the body known as diuretics, such as amiloride, spironolactone, acetazolamide and metolazone.
• medicines used to treat unusual heart beats, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol and mexiletine.
• medicines used to treat angina that you spray or dissolve under your tongue such as glyceryl trinitrate or isosorbide dinitrate.
• warfarin, used to prevent atrial fibrillation, unwanted clotting and stroke.
• medicines used to treat high cholesterol, such as clofibrate, colestyramine or colestipol.
• moxisylyte used to treat Raynaud's syndrome.
• medicines used to treat pain and inflammation known as NSAIDs, such as indometacin or salicylates such as aspirin.
• medicines used to treat inflammation known as corticosteroids, such as prednisolone and dexamethasone.
• medicines used to treat infections caused by bacteria, such as lymecycline, vancomycin, gentamicin, trimethoprim, cephaloridine, ceftriaxone and colistin.
• medicines used to treat infections caused by fungus, such as amphotericin.
• medicines used to treat infections caused by a virus, such as nelfinavir, ritonavir and saquinavir drugs used after transplants, such as tacrolimus, ciclosporin, aldesleukin.
• medicines used for depression, such as reboxetine, amitriptyline and phenelzine.
• medicines used for mental problems called ‘psychoses’, such as risperidone (see section ‘Do not take Drolina’), amisulpride, sertindole, pimozide and chlorpromazine. Avoid using pimozide at the same time as furosemide lithium, used to treat extreme mood swings
• medicines used to help you sleep, such as chloral hydrate and triclofos.
• atomoxetine used to treat Attention Deficit Hyperactivity Disorder (ADHD).
• medicines used to treat epilepsy, such as carbamazepine, phenobarbital and phenytoin.
• medicines used to treat Parkinson’s disease such as levodopa, medicines used to treat diabetes, medicines to treat asthma, such as salmeterol, salbutamol and theophylline. These medicines also treat chronic obstructive pulmonary disease.
• medicines used to treat blocked noses, such as ephedrine and xylometazoline.
• medicines used to treat cancer such as cisplatin, methotrexate and aminoglutethimide.
• medicines to relax muscles such as baclofen and tizanidine laxatives that help you go to the toilet.
• alprostadil, used to treat male impotence oestrogen and drospirenone, used as contraceptives or in hormone replacement therapy (HRT) .
• probenecid, used to treat gout potassium salts used to treat low potassium in the blood sucralfate, used to treat stomach ulcers. Do not take sucralfate within two hours of taking Drolina. This is because the sucralfate can stop the Drolina from working properly.
• antihistamines, used to treat allergies such as cetirizine.
• medicines or food containing liquorice.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Drolina.

Drolina with food, drink and alcohol
You should avoid drinking alcohol while taking Drolina as this may lower your blood pressure further.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine if you are breast-feeding.

Driving and using machines
While taking this medicine you may feel less alert than normal. If this happens, do not drive a car or use any tools or machines.

Drolina contains liquid ethyl maltol and propylene glycol:
• liquid ethyl maltol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May have a mild laxative effect.
• This medicine contains 450 mg propylene glycol in each 1 ml.
• Propylene glycol threshold for babies less than 4 weeks is 1 mg/kg/day.
• If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
• Propylene glycol threshold for children less than 5 years old, Pregnant women and patient with liver and kidney diseases is 50mg/kg/day.
• If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
• If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
• If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
• This medicine contains less than 1 mmol of sodium, that is to say essentially "sodium-free"

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
 

Taking this medicine
• this medicine contains 1mg of furosemide in each 1ml
• take this medicine by mouth
• this medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes:
1.ensure the tube is clear before taking the medicine.
2.flush the tube with a minimum of 5mL of water.
3.administer the medicine gently and slowly into the tube, with a suitable measuring device.
4.flush the tube again with a minimum of 5mL of water. A 10mL flush volume should be used for large bore size tubes (18 Fr).
• it is best to take your dose in the morning
• plan your doses so that they do not affect your personal activities and sleep.
• ask your doctor or pharmacist to help you plan the best time to take this medicine.

Adults
The usual dose for adults is:
• 40mg each day
• take the dose prescribed by your doctor.

Use in children
The usual dose for children is:
• The correct dose will be worked out by the doctor according to the child’s body weight
 

Older People
If you are an older person, your doctor may start you on a lower dose and gradually raise this dose.
 

If you take more Drolina than you should
If you take more of the medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you som the doctor knows what you have taken.
 

If you forget to take Drolina
• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
If you have any of the following side effects while taking your medicine tell your doctor immediately or go to hospital straight away:
• severe allergic reaction which may include a skin rash, itching, dermatitis, peeling skin, sensitivity to sunlight or sun lamps or fever, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
• Inflammation of blood vessels (vasculitis, which may cause rash, fever and joint or muscle pains) or kidney inflammation, this may change the number of times you pass urine or you may see blood in your urine. You may have a fever, feel drowsy, or notice swelling e.g. of the ankles.
• Blood clot (causing pain, swelling or tenderness in the legs).

If you get any of the following side effects, see your doctor as soon as possible:
Very common: may affect more than 1 in 10 people
• dehydration
• altered balance of fluid or chemicals in the body (e.g. sodium, potassium, chlorine, calcium and magnesium) causing a dry mouth, weakness, tiredness or drowsiness, restlessness, fits, muscle pain fatigue or cramps, low pressure causing loss of concentration and slowed reactions, difficulty passing water, fast or irregular heart rate and feeling and being sick.
Common: may affect up to 1 in 10 people
• low blood volume (hypovolaemia)
• increased creatinine and blood urea (seen in blood tests).

Uncommon: may affect up to 1 in 100 people
• anemia causing tiredness, breathlessness, unusual bleeding or bruising.
• changes in the body seen in tests such as levels of cholesterol, glucose, uric acid.
• gout.
• changes in vision including blurred or yellow vision.
• Light-headedness, sensations of pressure in the head, headache, drowsiness, weakness, changes in vision, dry mouth, and dizziness when standing.
• irregular heartbeat.
• muscle cramps or weakness.
• changes in the amount or need to urinate.
• tiredness.
• dry mouth, thirst.
• feeling or being sick.
• changes in bowel movements including diarrhea and constipation
• Deafness (sometimes irreversible).
Rare: may affect up to 1 in 1,000 people
• changes in blood cells such as amount of white blood cells, reduction of platelets causing a rash fever, sweating, tiredness, and weight loss.
• Your doctor will perform regular blood tests to ensure no changes have occurred.
• psychiatric disorder NOC causing delusions, hallucinations, disorganized speech.
• feeling ‘pins and needles’ or tingling sensation.
• confusion.
• headache.
• ringing’ in the ears, loss of hearing usually reversible.
• symptoms of shock such as changes in heart rate, breathlessness, cool clammy skin.
• inflammation of the pancreas causing pains in your abdomen or back and nausea.
• changes in the liver causing yellowing of the skin or whites of the eyes.
• skin rashes.
• tiredness, generally feeling unwell.
• fever.
• acute kidney failure.
Very rare: may affect up to 1 in 10,000 people
• involuntary movements of the muscle.
• inflammation or failure of the kidney which may cause back pain or changes in the amount or need to urinate.
Not known: frequency cannot be estimated from the available data
• worsening of conditions where there is already balances of fluid or chemicals in the body.
• acute generalized exanthemata’s pustulosis (AGEP) (acute febrile drug eruption).
• dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).
• decreased levels of potassium in the body.

This medicine may raise cholesterol and lipid (fat) levels in the blood. If this medicine is used in babies born too soon (prematurely), this medicine can cause:
• persistence of a blood channel that normally closes at or around birth. This may cause heart failure, failure to grow, shortness of breath and rapid pulse.
• kidney stones and/or calcium deposits in the body.

Tell your doctor if you get any of these side effects:
• feeling sick (nausea) or being sick (vomiting)
• generally feeling unwell.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

To report any side effect(s):
• Saudi Arabia:
ꟷ The National Pharmacovigilance Centre (NPC)
• Fax: +966-11-205-7662
• SFDA Call Center: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa

• Other GCC States:
Please contact the relevant competent authority.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
• Keep this medicine in the original pack to protect from light.
• Do not store above 30°C. After Opening use within month.
• Do not use this medicine if you notice that the pack is changed or showing signs of tampering.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment