1. What this product is and what it is used for
DIZINIL contains dimenhydrinate as the active ingredient. It belongs to a group called antihistamines. It works by reducing symptoms of vertigo (a feeling of dizziness or ’spinning’) and nausea (feeling sick).
DIZINIL is used mainly as antiemetic therapy in the prevention and treatment of motion sickness, postoperative vomiting, drug-induced nausea and vomiting, and the symptomatic treatment of nausea and vertigo due to Ménière’s disease and labyrinthitis.
2. What you need to know before you use this product
Do not take DIZINIL if you:
• are allergic to dimenhydrinate 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,
• suffer from alcohol abuse,
• have prostate problems which cause difficulty in urinating,
• suffer from liver or kidney failure
Not recommended for the children under age of 2 years
Warnings and precautions
Talk to your doctor or pharmacist before taking DIZINIL if you suffer from:
• low or high blood pressure,
• raised pressure in the eye,
• an enlarged prostate,
• severe heart disease,
The use of DIZINIL may make these conditions worse. DIZINIL may still be suitable for you but your doctor may need to take these facts into account.
Other medicines and DIZINIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. DIZINIL may interact with other medicines that you are taking.
DIZINIL 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
• tranquillisers (a type of medicine used to treat depression and anxiety)
• monoamine oxidase inhibitors (used to treat depression and anxiety)
DIZINIL may increase the effects of the following medicines:
• tricyclic antidepressants (used to treat depression and anxiety)
• medicines taken to lower blood pressure
Aminoglycosides (a type of antibiotic) can damage the inner ear. If you take DIZINIL you may not notice that this damage is happening.
You should not take DIZINIL with drugs that are used to correct problems with your heart beat (anti-arrhythmics). DIZINIL may also change the way your skin reacts to allergy tests.
DIZINIL with food and drink
DIZINIL can cause indigestion that can be reduced by taking the tablets after meals. Do not drink alcohol while taking DIZINIL because it may make you tired or sleepy.
Pregnancy, breast-feeding and fertility
Do not take DIZINIL if you are pregnant or are breast-feeding or think you might be pregnant.
Driving and using machines
DIZINIL may make you feel sleepy. If this occurs you should not drive or operate machinery.
Important information about some of the ingredients in DIZINIL
DIZINIL contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use this product.
Always take DIZINIL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
Adults:
For motion sickness it is usually given in doses of 50 mg three times daily, the first
dose for preventing motion sickness being taken about 30 minutes before the journey.
For other treatment, 4-hourly administration may be required. Doses of 100 mg may be required but a daily total of 300 mg should not usually be exceeded.
Children:
2 to 6 years: 12.5 to 25 mg two to three times daily. Not more than 75 mg should be given in any 24 hours. Do not exceed the stated dose.
7 to 12 years: 25 to 50 mg two to three times daily. Not more than 150 mg should be given in any 24 hours. Do not exceed the stated dose.
Elderly:
Same as adult dose
If you take more DIZINIL than you should
If you accidentally take too many tablets or if a child takes some, you should seek medical advice urgently or go to your nearest hospital casualty/accident and emergency department.
If you forget to take DIZINIL
• Take the missed dose as soon as remembered.
• If it is almost time for next regular dose, wait until then to take the medicine and skip the missed dose.
• Do not take two doses at one time.
If you stop taking DIZINIL
Do not stop taking DIZINIL 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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse effects with dimenhydrinate may vary in incidence and severity from patient to patient.
The most common effect is sedation which may vary from slight drowsiness to deep sleep. Dimenhydrinate may be associated with inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination. When they do occur the sedative effects may diminish after a few days.
Rare with Dimenhydrinate are gastro-intestinal side effects.
Dimenhydrinate may very rarely produce headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness in the mouth, tightness in the chest, tingling, heaviness and weakness of the hands.
Although cardio-vascular side effects are rare, minor increases in blood pressure and occasional mild hypotension have been reported. Leucopenia and rarely agranulocytosis, jaundice and extra-pyramidal reactions have also been reported.
Occasionally hypersensitivity reactions have followed its uses by mouth. These include bronchospasm, angioedema, rashes and photosensitivity.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
§ Saudi Arabia:
The National Pharmacovigilance Centre (NPC):
- SFDA Call Centre: 19999
- E-mail: [email protected]
- Website: https://ade.sfda.gov.sa/
§ Other GCC States:
- Please contact the relevant competent authority.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store this product
- Keep out of the reach and sight of children.
- Do not use DIZINIL after the expiry date which is stated on the carton and on the blister.
- Store below 30°C, in a dry place.
- Do not use DIZINIL if you notice any visible sign of deterioration.
- 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.
