TRAZODONE HYDROCHLORIDE 150 MG TABLETS, MOLIPAXIN 150 MG TABLETS - patient leaflet, side effects, dosage

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Molipaxin 150mg Tablets

Trazodone hydrochloride

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Molipaxin Tablets are and what they are used for

• 2. Before you take Molipaxin Tablets

• 3. How to take Molipaxin Tablets

• 4. Possible side effects

• 5. How to store Molipaxin Tablets

• 6. Further information

• 1. What Molipaxin Tablets are and what they are used for

The name of your medicine is Molipaxin 150mg Tablets (called Molipaxin Tablets in this leaflet). Molipaxin Tablets contain a medicine called trazodone hydrochloride. This belongs to a group of medicines called antidepressants.

Molipaxin Tablets can be used to treat anxiety and depression.

• 2. Before you take Molipaxin Tablets

Do not take this medicine and tell your doctor if you:

• are allergic to trazodone hydrochloride or any of the other ingredients of Molipaxin Tablets (listed in section 6). Signs of an allergic reaction can include: a rash, swallowing or breathing problems, swelling _____ of your lips, face, throat or tongue.
• ; have recently had a heart attack.
• are a heavy drinker or are taking sleeping tablets.
• are under 18 years of age.

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

Take special care with Molipaxin Tablets Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this if you:

• have previously had thoughts about killing or harming yourself.
• are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Molipaxin Tablets should not be used in children and adolescents under 18 years of age.

If you are elderly, you may be more prone to side effects, increased caution is necessary especially when taking other medicines at the same time as Molipaxin or you have some other diseases.

Check with your doctor or pharmacist before taking this medicine if you:

• have or have ever had fits or seizures (epilepsy)
• have severe liver, kidney or heart problems
• are pregnant, trying to become pregnant or are breast-feeding
• have an overactive thyroid gland (hyperthyroidism)
• have problems passing water or need to pass water (urine ) frequently
• have narrow angle glaucoma (an eye disorder)
• have schizophrenia or other type of mental disorder
• are elderly, as you may be more prone to side effects
• are taking buprenorphine (a strong pain killer). The use of buprenorphine with Molipaxin Tablets can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Molipaxin Tablets”).

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

Other medicines and Molipaxin Tablets Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Molipaxin Tablets can affect the way some other medicines work. Also some medicines can affect the way Molipaxin Tablets work.

Tell your doctor if you are taking any of the following medicines:

• MAOI (MonoAmine Oxidase Inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s di­sease), or have taken them in the last 2 weeks
• Other antidepressants (such as amitriptyline or fluoxetine)
• Buprenorphine/o­pioids. These medicines may interact with Molipaxin Tablets and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as carbamazepine and phenytoin
• Medicines used to treat high blood pressure, for example, clonidine
• Digoxin (used to treat heart problems)
• Medicines used to treat fungal infections such as ketoconozole and itraconazole
• Some medicines used to treat HIV such as ritonavir and indinavir
• Erythromycin, an antibiotic used to treat infections
• Levodopa (used to treat Parkinson’s di­sease) St. John’s Wort (a herbal remedy) Warfarin (used to stop your blood from clotting)

Anaesthetics

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking Molipaxin Tablets.

Taking Molipaxin Tablets with food and drink

You should avoid drinking alcohol while taking Molipaxin Tablets

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

Molipaxin Tablets should only be taken during pregnancy if your doctor tells you that treatment with Molipaxin Tablets is essential for you and tells you to take this medicine.

Taking Molipaxin Tablets in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they are born. If you are breast-feeding or planning to breastfeed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

Molipaxin Tablets may make you feel sleepy or dizzy. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of Molipaxin Tablets Lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take molipaxin tablets

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• Your doctor may increase the dose to 300mg each day

Elderly

• Older people or those who are frail will usually be given a starting dose of 100mg each day

Children

Children and adolescents under 18 years should not take Molipaxin Tablets.

If you take more Molipaxin Tablets than you should

If you take more Molipaxin Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

The following effects may happen: feeling sick or being sick, feeling sleepy, dizzy or faint, fits (seizures), confusion, breathing or heart problems.

If you forget to take Molipaxin Tablets

If you forget to take 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 to make up for a forgotten dose.

If you stop taking Molipaxin Tablets

Keep taking Molipaxin Tablets until your doctor tells you to stop. Do not stop taking Molipaxin Tablets just because you feel better. When your doctor tells you to stop taking these tablets he/she will help you to stop taking them gradually.

4. possible side effects

Like all medicines, Molipaxin Tablets can cause side effects, although not everybody gets them.

• Stop taking Molipaxin Tablets and see a doctor or go to a hospital straight away if: You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash. This may mean you are having an allergic reaction to Molipaxin Tablets
• Painful erection of the penis, unrelated to sexual activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a liver problem (such as jaundice)
• Getting infections more easily than usual. This could be because of a blood disorder (agranulocytosis)
• Bruising more easily than usual. This could be because of a blood disorder (thrombocytopenia)
• You have severe abdominal pain and bloating, are being sick (vomiting) and have constipation. These may be signs that your intestine is not working properly (paralytic ilius)

Talk to your doctor straight away if you notice the following side-effects:

• You have thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of anaemia
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (parasthesia)
• Feeling confused, restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat, you may have something called Serotonin syndrome.
• Feeling very unwell, possibly with shortness of breath (dyspnoea), difficulty in walking or walking with a shuffling gait, shaking, uncontrolled muscle twitching and a high temperature (above 38°C). This could be a rare condition known as Neuroleptic Malignant Syndrome.
• Rapid, slow or irregular heartbeat.

Below is a list of other side effects that have been reported:

• Feeling drowsy or sleepy, tiredness
• Feeling less alert than usual
• Feeling sick (nausea) or being sick (vomiting), indigestion
• Constipation, diarrhoea
• Dry mouth, altered taste, increased amounts of saliva, blocked nose
• Sweating more than usual
• Dizziness, headache, confusion, weakness, tremor (shaking)
• Blurred vision
• Loss of appetite and weight loss
• Feeling dizzy or light-headed on standing or sitting up quickly (postural hypotension) , fainting (syncope)
• Feeling restless and having difficulty sleeping
• Water retention which may cause swollen arms or legs
• Skin rash, itching
• Chest pain
• Pain in limbs, back pain, pain in your muscles, pain in your joints
• Jerking movements that you can not control, mainly in the arms and legs, uncontrolled muscle movements or twitches
• Frequent infections with high temperature, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem

called leucopenia.

• Feeling anxious or more nervous than usual, feeling agitated
• Overactive behaviour or thoughts (mania), believing things that are not true (delusions), memory disturbance
• Nightmares
• Decreased sex drive
• Feeling dizzy, possibly with a “spinning” feeling (vertigo)
• High blood pressure
• High temperature
• Flu type symptoms
• Difficulty with speaking
• Higher than normal number of white blood cells (seen by a blood test)
• High levels of liver enzymes in your blood (shown by a blood test)
• Severe liver disorders such as hepatitis
• Liver failure with potentially fatal outcome
• Feeling tired, weak and confused, having muscles that ache, are stiff or do not work well. There may also be headache, loss of appetite, nausea or vomiting, convulsion. This may be due to low sodium levels in your blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store molipaxin tablets

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Molipaxin Tablets after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store below 30°C. Store in the original packaging in a dry place.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• 6. Further information

What Molipaxin Tablets contains

• Each Molipaxin 150mg Tablet contains 150mg of the active substance, trazodone hydrochloride
• Other ingredients include lactose, calcium hydrogen phosphate, microcrystalline cellulose, maize starch, sodium starch glycollate, povidone and magnesium stearate, hydroxypropyl methyl cellulose, propylene glycol, red iron oxide (E172) and titanium dioxide (E171).

What Molipaxin Tablets looks like and contents of the pack

A salmon pink film-coated tablet with “Molipaxin” and “150” on one face and a breakline on the other. The tablets are available in blister packs of 28.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva Pharma UK Limited,

12 New Fetter Lane, London EC4A 1JP, United Kingdom

Manufacturer

Zentiva, k. s.

U Kabelovny 130

102 37 Prague 10

Dolni Mecholupy

Czech Republic

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in February 2021

© Zentiva, 2021

ZV/651 92

Z0NTIVA

----------------- REASON OF REVISION: ------------------

Type IB variation to implement the PRAC recommended text relating to: Drug-drug interaction with serotonergic drugs leading to serotonin syndrome. Excipients text to be updated. Artwork is required for the submission. ZTL Trazodone – CMDh recommendation 2020–09–24 : 2020–09–24

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