Patient leaflet - Cinnarizine/dimenhydrinate 20 mg/40 mg tablets

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

Cinnarizine/dimenhydrinate tablets contain two active ingredients. One is cinnarizine and the other 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.

Cinnarizine/dimenhydrinate tablets are 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
if you are allergic to cinnarizine, dimenhydrinate or
diphenhydramine or any of the other ingredients of this medicine (listed in section 6)
if you 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 by your doctor. - if you suffer from angle-closure glaucoma (a speciﬁc
type of eye disease)
if you have epilepsy
if you have increased pressure in the brain (e.g. due
to a tumour)
if you suffer from alcohol abuse
if you have prostate problems which cause difﬁculty
in urinating
if you suffer from liver or kidney failure.
Cinnarazine/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 for up to 4 weeks. Your doctor will tell you if you need to take cinnarizine/dimenhydrinate for any longer.

If you take more cinnarizine/dimenhydrinate 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 of cinnarizine/dimenhydrinate 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 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 the cinnarizine/dimenhydrinate tablets

If you forget to take a tablet of cinnarizine/dimenhydrinate 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 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.

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 Cinnarizine/Dimenhydrinate 20 mg/ 40 mg tablets

cinnarizine/dimenhydrinate

Package leaﬂet: Information for the patient

		Code No. : WOA WA Reason for Change 1) Product : Cinnarizine/Dimenhydrinate tablets - BBUK 2) Strength : 20 mg/40 mg 3) Component : Leaflet 4) No of colours : 01 5) Dimension : 150(L) x 320(W) mm NA
							Revision: 00
							Date: 08-11-23
	Reviewed by		Reviewed by	Reviewed by	Reviewed by
Department	Contract Giver/ PL holder		Regulatory Affairs		Head Production/ Packing (Site)	Head QA (Site)
Sign / Date

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.

Do not store above 30C.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Content of the pack and other information

What Cinnarizine/Dimenhydrinate tablets contain

The active substances are: cinnarizine and dimenhydrinate. Each tablet contains 20 mg cinnarizine and 40 mg dimenhydrinate. - The other ingredients are: maize starch, croscarmellose sodium, cellulose microcrystalline, hypromellose, silica colloidal anhydrous, talc and magnesium stearate.

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

White to off-white, round, biconvex, uncoated tablets debossed with 'C' on one face and plain on other face with a diameter of approximately 8.00 mm.

Cinnarizine/Dimenhydrinate tablets are available in blister packs.

Pack sizes: 10, 20, 25, 28, 30, 40, 50, 60, 70, 80, 90 and 100 tablets.

Not all pack size may be marketed.

Marketing Authorisation Holder and Manufacturer:

Brown & Burk UK Ltd

Micro House

5 Marryat Close, Hounslow

TW4 5DQ

United Kingdom

This leaﬂet was last revised in {10/2023}.

Other sources of information:

To request a copy of this leaﬂet in Braille, large print or audio, please contact phone +44 208 577 8200 / 208 622 3174

Prescription needed??	Yes, prescription-only medicine (POM)
Active substances?	Dimenhydrinate, Cinnarizine
Strength?	20 mg/40 mg
Pharmaceutical form?	Oral tablet White to off-white, round, biconvex, uncoated tablets debossed with ‘C’ on one face and plain on other face with a diameter of approximately 8.00 mm.
How is it taken?	Oral
Excipients?	Maize starch, Croscarmellose sodium, Cellulose, microcrystalline (Grade 101 and 102), Hypromellose (5 mPa S), Silica, colloidal anhydrous (Grade 200), Talc, Magnesium stearate
Pack sizes	100 tablet
Is it available??	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life?	3 years
Storage	Do not store above 30°C.
Drug group (ATC)?	Antivertigo preparations N Nervous system drugs N07 Other nervous system drugs N07C Antivertigo preparations N07CA Antivertigo preparations N07CA52 cinnarizine, combinations
Marketing authorisation?	PL 25298/0366 (first authorised 12 December 2023)
Marketing authorisation holder?	Brown & Burk UK Ltd
Codes?	GTIN 5060124642833 · BNF 04060000

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