Delaxin is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Delaxin belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).

Delaxin is also used to treat or manage:

• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia (FM)
• Chronic Musculoskeletal Pain

Do not take Delaxin if you:

• Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.

-    Do not take an MAOI within 5 days of stopping Delaxin unless directed to do so by your healthcare provider.

-    Do not start Delaxin if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.

People who take Delaxin close in time to an MAOI may have a serious problem called Serotonin Syndrome (see “4. Possible side effects”).

Warnings and precautions

Before starting Delaxin, tell your healthcare provider if you:

• Have heart problems or high blood pressure
• Have diabetes (Delaxin treatment makes it harder for some people with diabetes to control their blood sugar)
• Have liver problems
• Have kidney problems
• Have glaucoma
• Have or had seizures or convulsions
• Have bipolar disorder or mania
• Have low sodium levels in your blood
• Have delayed stomach emptying
• Have or had bleeding problems
• Are pregnant or plan to become pregnant. Duloxetine may harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take Delaxin during pregnancy. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Delaxin.
• Are breastfeeding or plan to breastfeed. Duloxetine passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby while taking duloxetine.

Other medicines and Delaxin

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Delaxin and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Especially tell your healthcare provider if you take:

• Triptans used to treat migraine headache
• Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs or MAOIs
• Tramadol and fentanyl
• Amphetamines
• Cimetidine
• The antibiotics ciprofloxacin, enoxacin
• Medicine to treat irregular heart rate (like propafenone, flecainide, quinidine)
• Theophylline
• The blood thinner warfarin
• Non-steroidal anti-inflammatory drug (NSAID) (like ibuprofen, naproxen or aspirin).
• Over-the-counter supplements such as tryptophan or St. John’s Wort
• Thioridazine. Thioridazine together with duloxetine can cause serious heart rhythm problems or sudden death.

Ask your healthcare provider for a list of these medicines if you are not sure.

Do not take Delaxin with any other medicine that contain duloxetine.

Delaxin with food and alcohol

Delaxin may be taken with or without food.

Use of Delaxin concomitantly with heavy alcohol intake may be associated with severe liver injury. Avoid heavy alcohol use while taking Delaxin.

Pregnancy and breast-feeding

Before starting Delaxin, tell your healthcare provider if you:

• Are pregnant or plan to become pregnant. Duloxetine may harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take Delaxin during pregnancy. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Delaxin.
• Are breastfeeding or plan to breastfeed. Duloxetine passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby while taking duloxetine.

Driving and using machines

Delaxin can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Delaxin affects you.

Delaxin contains sucrose

Delaxin contains sucrose. Each hard gastro-resistant capsule of Daltix 30 mg and 60 mg Hard Gastro-resistant Capsules contains 64.23 mg or 128.46 mg sucrose; respectively. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• Take Delaxin exactly as your healthcare provider tells you to take it. Your healthcare provider may need to change the dose of Delaxin until it is the right dose for you.
• Swallow Delaxin whole. Do not chew or crush Delaxin.
• Do not open the capsule and sprinkle on food or mix with liquids. Opening the capsule may affect how well Delaxin works.
• Delaxin may be taken with or without food.
• When switching from another antidepressant to Delaxin your healthcare provider may want to lower the dose of the initial antidepressant first to potentially avoid side effects.

If you take more Delaxin than you should

If you take too much Delaxin, call your healthcare provider right away, or get emergency treatment.

If you forgot to take Delaxin

If you miss a dose of Delaxin, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Delaxin at the same time.

Delaxin may cause serious side effects, including:

Common possible side effects in people who take duloxetine include:

Liver damage. Symptoms may include:

• Itching
• Right upper abdominal pain
• Dark urine
• Yellow skin or eyes
• Enlarged liver
• Increased liver enzymes

Changes in blood pressure and falls. Monitor your blood pressure before starting and throughout treatment. Duloxetine may:

• Increase your blood pressure.
• Decrease your blood pressure when standing and cause dizziness or fainting, mostly when first starting duloxetine or when increasing the dose.
• Increase risk of falls, especially in elderly.

Serotonin Syndrome: This condition can be life-threatening and symptoms may include:

• Agitation, hallucinations, coma or other changes in mental status
• Coordination problems or muscle twitching (overactive reflexes)
• Racing heartbeat, high or low blood pressure
• Sweating or fever
• Nausea, vomiting, or diarrhea
• Muscle rigidity
• Dizziness
• Flushing
• Tremor
• Seizures

Abnormal bleeding: Duloxetine and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin, a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

Severe skin reactions: Duloxetine may cause serious skin reactions that may require stopping its use. This may need to be treated in a hospital and may be life-threatening. Call your healthcare provider right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions.

Discontinuation symptoms: Do not stop Delaxin without first talking to your healthcare provider. Stopping duloxetine too quickly or changing from another antidepressant too quickly may result in serious symptoms including:

• Anxiety
• Irritability
• Feeling tired or problems sleeping
• Headache
• Sweating
• Dizziness
• Electric shock-like sensations
• Vomiting or nausea
• Diarrhea

Manic episodes:

• Greatly increased energy
• Severe trouble sleeping
• Racing thoughts
• Reckless behavior
• Unusually grand ideas
• Excessive happiness or irritability
• Talking more or faster than usual

Visual problems:

• Eye pain
• Changes in vision
• Swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Seizures or convulsions.

Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

• Headache
• Weakness or feeling unsteady
• Confusion, problems concentrating or thinking or memory problems

Problems with urination. Symptoms may include:

• Decreased urine flow
• Unable to pass any urine

Sexual problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including duloxetine, may cause sexual problems.

Symptoms in males may include: 

• Delayed ejaculation or inability to have an ejaculation 
• Decreased sex drive
• Problems getting or keeping an erection

Symptoms in females may include:

• Decreased sex drive  
• Delayed orgasm or inability to have an orgasm

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with duloxetine. There may be treatments your healthcare provider can suggest.

The most common side effects of duloxetine include:

• Nausea
• Dry mouth
• Sleepiness
• Fatigue
• Constipation
• Loss of appetite
• Increased sweating
• Dizziness

Common possible side effects in children and adolescents who take duloxetine include:

• Nausea
• Decreased weight
• Dizziness

Side effects in adults may also occur in children and adolescents who take Delaxin. Children and adolescents should have height and weight monitored during treatment.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Delaxin. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Store in the original package.

Shelf-life for this medicine after opening the bottle is 4 weeks at 30°C.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

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.