Cinnarizine/dimenhydrinate Torrent 20 mg/40 mg tablets – patient leaflet, side effects, dosage

1. What Cinnarizine/dimenhydrinate tablets are and what they are used for

Cinnarizine/dimenhydrinate tablets contains two active ingredients. One is cinnarizine and one is dimenhydrinate. The two substances belong to different groups of medicines. Cinnarizine is part of a group called calcium antagonists. Dimenhydrinate belongs to a group called antihistamines. Both substances work by reducing symptoms of vertigo (a feeling of dizziness or ’spinning’) and nausea (feeling sick). When these two substances are used together they are more effective than when each one is used on its own.

Arlevert is used for the treatment of various kinds of vertigo in adults. Vertigo can have a number of different causes. Taking Cinnarizine/dimenhydrinate tablets can help you carry on with daily activities that are difficult when you have vertigo.

2. What you need to know before you take Cinnarizine/dimenhydrinate tablets

Do not take Cinnarizine/dimenhydrinate tablets if you:

• are under the age of 18 years.

• are allergic to cinnarizine, dimenhydrinate or diphenhydramine or any of the other ingredients of this

  medicine (listed in section 6).

• are allergic to any other antihistamines (such as astemizole, chlorpheniramine and terfenadine, used

  as allergy medicines). You should not take this medicine unless you have been told to by your doctor.

• suffer from angle-closure glaucoma (a specific type of eye disease).
• have epilepsy.
• have increased pressure in the brain (e.g. due to a tumour).
• suffer from alcohol abuse.
• have prostate problems which cause difficulty in urinating.
• suffer from liver or kidney failure.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Cinnarizine/dimenhydrinate tablets if you suffer from:

• low or high blood pressure,
• raised pressure in the eye,
• obstruction in the bowels,
• an enlarged prostate,
• an overactive thyroid,
• severe heart disease,
• Parkinson’s disease.

The use of Cinnarizine/dimenhydrinate tablets may make these conditions worse. Cinnarizine/dimenhydrinate tablets may still be suitable for you but your doctor may need to take these facts into account.

Other medicines and Cinnarizine/dimenhydrinate tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Cinnarizine/dimenhydrinate tablets may interact with other medicines that you are taking. Cinnarizine/dimenhydrinate tablets can make you tired or sleepy when taken with the medicines listed below:

• barbiturates (medicines that are often taken to calm you down)
• narcotic analgesics such as morphine (strong painkillers such as morphine)
• tranquillisers (a type of medicine used to treat depression and anxiety)
• monoamine oxidase inhibitors (used to treat depression and anxiety)

Cinnarizine/dimenhydrinate tablets may increase the effects of the following medicines:

• tricyclic antidepressants (used to treat depression and anxiety)
• atropine (a medicine that relaxes muscles and is often used to examine your eye)
• ephedrine (can be used to treat cough or blocked nose)
• procarbazine (a medicine used to treat some kinds of cancer)
• medicines taken to lower blood pressure

Amino glycosides (a type of antibiotic) can damage the inner ear. If you take Cinnarizine/dimenhydrinate tablets you may not notice that this damage is happening.

You should not take Cinnarizine/dimenhydrinate tablets with drugs that are used to correct problems with your heart beat (anti arrhythmics). Cinnarizine/dimenhydrinate tablets may also change the way your skin reacts to allergy tests.

Cinnarizine/dimenhydrinate tablets with food, drink and alcohol

Cinnarizine/dimenhydrinate tablets can cause indigestion that can be reduced by taking the tablets after meals. Do not drink alcohol while taking Cinnarizine/dimenhydrinate tablets because it may make you tired or sleepy.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

Cinnarizine/dimenhydrinate tablets may make you feel sleepy. If this occurs you should not drive or operate machinery.

Cinnarizine/dimenhydrinate tablets contain sodium

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

3. How to take Cinnarizine/dimenhydrinate tablets

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

The recommended dose is one tablet three times daily, with some liquid after meals. Swallow the tablet whole, do not chew. Usually you will take Cinnarizine/dimenhydrinate tablets for up to 4 weeks. Your doctor will tell you if you need to take Cinnarizine/dimenhydrinate tablets for any longer. If you take more Cinnarizine/dimenhydrinate tablets than you should

If you accidentally take too many tablets or if a child takes some, you should seek medical advice urgently. If you take too much Cinnarizine/dimenhydrinate tablets you may become very tired, dizzy and shaky. Your pupils might dilate and you may not be able to urinate. Your mouth may feel dry, your face flush, you may have a faster heart rate, fever, sweat and have a headache.

If you have taken a massive amount of Cinnarizine/dimenhydrinate tablets you could have fits, hallucinations, high blood pressure, feel shaky, get excited, and find it difficult to breathe. Coma could occur.

If you forget to take Cinnarizine/dimenhydrinate tablets

If you forget to take a tablet of Cinnarizine/dimenhydrinate tablets just miss out that tablet. Take the next tablet of Cinnarizine/dimenhydrinate the next time when you would usually take it. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Cinnarizine/dimenhydrinate tablets

Do not stop taking Cinnarizine/dimenhydrinate tablets before your doctor tells you to. You are likely to have the symptoms of vertigo again (dizziness and ’spinning’) if you stop treatment too soon. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people): drowsiness, dry mouth, headache, and stomach pain. These are usually mild and disappear within a few days even if you keep taking Cinnarizine/dimenhydrinate tablets.

Uncommon side effects (may affect up to 1 in 100 people): sweating, reddening of the skin, indigestion, nausea (feeling sick), diarrhoea, nervousness, cramps, forgetfulness, tinnitus (ringing in the ear), paraesthesia (tingling of the hands or feet), tremor (shaking).

Rare side effects (may affect up to 1 in 1,000 people): impaired vision, allergic reactions (e.g. skin reactions), light sensitivity, and difficulty in urinating.

Very rare side effects (may affect up to 1 in 10,000 people): white blood cell and platelet counts may be lowered, and red blood cells may be severely reduced, which can cause weakness, bruising or make infections more likely. If you suffer from infections with fever and serious deterioration of your general health, see your doctor and tell him about your medicine.

Other possible reactions (frequency cannot be estimated from the available data) which may occur with this type of medicine include: weight gain, constipation, tightness of the chest, jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems), worsening of an angle-closure glaucoma (an eye disease with increased pressure inside the eye), uncontrollable movements, unusual excitement and restlessness (especially in children), severe skin reactions.

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: www.mhra.gov.uk/yellowcard 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 Cinnarizine/dimenhydrinate tablets

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 blister and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions. Store in the original package.

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.

6. Contents of the pack and other information

What Cinnarizine/dimenhydrinate tablets contain

• The active substances are: cinnarizine 20 mg and dimenhydrinate 40 mg.
• The other ingredients are: microcrystalline cellulose, maize starch, croscarmellose sodium, hypromellose 2910, colloidal silicon dioxide, magnesium stearate and talc.

What Cinnarizine/dimenhydrinate tablets look like and contents of the pack

Cinnarizine/dimenhydrinate tablets are white to off white, round, uncoated tablets debossed with ‘V5’ on one side, and plain on other side with a diameter of approximately 8 mm.

Tablets are packed in Aluminium-Aluminium blisters or PVC/PVDC-Aluminium blisters. They are available in packs containing 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Torrent Pharma (UK) Ltd.

3rd Floor, Nexus Building

4 Gatwick Road

Crawley

West Sussex

RH10 9BG

United Kingdom

This leaflet was last revised in 05/2024.

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8096036-7803