Agivert

Package leaflet: Information for the user

AGIVERT 20 mg/40 mg tablets

cinnarizine/dimenhydrinate
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:
1 What Agivert is and what it is used for
2 What you need to know before taking Agivert
3 How to take Agivert
4 Possible side effects
5 How to store Agivert
6 Contents of the pack and other information

1. What Agivert is and what it is used for

Agivert contains two active substances, cinnarizine and dimenhydrinate. These two substances belong to different groups of medicines. Cinnarizine belongs to the group of calcium antagonists, while dimenhydrinate belongs to a group of medicines called antihistamines.
Both substances work by reducing the symptoms of vertigo (a sensation of dizziness or spinning) and nausea (feeling of discomfort). When these two substances are used in combination, they are more effective than either substance used alone.
Agivert is used in adults for the treatment of various types of vertigo. Vertigo can have different causes. Taking Agivert may help you carry out your normal daily activities that are made difficult by vertigo.

2. What you need to know before taking Agivert

Do not take Agivert
If you are under 18 years of age.
If you are allergic to cinnarizine, dimenhydrinate, diphenhydramine, or any of the other ingredients of this
medicinal product (listed in section 6).
If you are allergic to any other antihistamine (such as astemizole, chlorpheniramine, or terfenadine, used as
antiallergic medicines). You must not take this medicine unless prescribed by your doctor.
If you have narrow-angle glaucoma (a specific type of eye disease).
If you have epilepsy.
If you have increased intracranial pressure (e.g. due to a tumour).
If you have a history of alcohol abuse.
If you have prostate problems causing difficulty in urination.
If you have hepatic or renal insufficiency.

Warnings and precautions
Consult your doctor or pharmacist before taking Agivert if you have:

• Low or high blood pressure,
• High intraocular pressure,
• Intestinal obstruction,
• Enlarged prostate,
• Hyperactive thyroid,
• Severe heart problems,
• Parkinson's disease.

The use of Agivert may worsen these conditions. However, Agivert may still be appropriate for you, but your doctor must take these factors into account.

Other medicines and Agivert
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Agivert may interact with other medicines you are taking.
Taking Agivert together with the following medicines may make you tired or drowsy:

• Barbiturates (medicines often taken to induce calmness)
• Opioid analgesics such as morphine (strong painkillers like morphine)
• Tranquillisers (a type of medicine used to treat depression and anxiety)
• Monoamine oxidase inhibitors (used to treat depression and anxiety)

Agivert may enhance the effects of the following medicines:

• Tricyclic antidepressants (used to treat depression and anxiety)
• Atropine (a medicine that relaxes muscles and is often used during eye examinations)
• Ephedrine (may be used to treat cough or nasal congestion)
• Procarbazine (a medicine used to treat certain types of cancer)
• Medicines used to lower blood pressure

Aminoglycosides (a type of antibiotic) can damage the inner ear. If you take Agivert, you may not notice such damage.
You must not take Agivert with medicines used to correct heart rhythm problems (antiarrhythmics). Agivert may also alter your skin's response to allergy testing.

Agivert with food, drinks and alcohol
Agivert may cause indigestion, which can be reduced by taking the tablets after meals. Do not drink alcohol during treatment with Agivert, as it may cause tiredness or drowsiness.

Pregnancy, breastfeeding and fertility
Do not take Agivert if you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding.

Driving and using machines
Agivert may cause drowsiness. If this occurs, do not drive or operate machinery.

3. HOW TO TAKE AGIVERT

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet three times a day, taken after meals with some liquid.
Swallow the tablet whole without chewing it. You will usually take Agivert for a maximum of 4 weeks. Your doctor will tell you if you need to take Agivert for a longer period.

If you take more Agivert than you should
If you accidentally take too many tablets or if a child has swallowed any, contact a doctor immediately.
Taking an excessive amount of Agivert may make you feel very tired, drowsy, and unsteady.
Your pupils may become dilated and you may be unable to urinate. You may experience dry mouth, facial flushing, increased heart rate, fever, sweating, and headache.
If you take a very large dose of Agivert, you may experience seizures, hallucinations, high blood pressure, tremors, agitation, and breathing difficulties. You may fall into a coma.

If you forget to take Agivert
If you forget to take a dose of Agivert, skip that dose. Take the next tablet at your usual scheduled time. Do not take a double dose to make up for the missed tablet.

If you stop taking Agivert
Do not stop treatment with Agivert unless your doctor tells you to. If you stop treatment too early, your vertigo symptoms (sensation of dizziness and spinning) are likely to return.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Common adverse effects (may affect up to 1 in 10 people)

• drowsiness
• dry mouth
• headache
• stomach discomfort
  These effects are generally mild and disappear within a few days, even while continuing treatment with Agivert.

Uncommon adverse effects (may affect up to 1 in 100 people)

• sweating
• skin flushing
• indigestion
• nausea (feeling unwell)
• diarrhea
• nervousness
• cramps
• forgetfulness
• tinnitus (ringing in the ears)
• paresthesia (tingling of hands or feet)
• tremor

Rare adverse effects (may affect up to 1 in 1,000 people)

• visual disturbances
• allergic reactions (e.g. skin reactions)
• light sensitivity
• difficulty urinating

Very rare adverse effects (may affect up to 1 in 10,000 people):

• reduction in the number of white blood cells and platelets
• marked reduction in the number of red blood cells, which may cause weakness, bruising, or increased risk of developing infections.

If you experience infections with fever and a significant worsening of your general health, consult your doctor and inform them about the medicine you are taking.

Other possible reactions (frequency cannot be estimated from the available data) that may occur with the use of this medicine include:

• weight gain
• constipation
• chest tightness
• jaundice (yellowing of the skin and whites of the eyes caused by blood or liver problems)
• worsening of closed-angle glaucoma (an eye disease characterized by increased pressure inside the eye)
• uncontrolled movements
• unusual excitement and restlessness (particularly in children)
• severe skin reactions.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AGIVERT

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Agivert contains

• The active substances are cinnarizine and dimenhydrinate. Each tablet contains 20 mg of cinnarizine and 40 mg of dimenhydrinate.
• The other components are: microcrystalline cellulose, pregelatinized starch, hypromellose, sodium croscarmellose, talc and magnesium stearate.

Description of the appearance of Agivert and pack contents
Agivert tablets are white, round and convex in shape.
Agivert is available in packs containing 20 or 50 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
FARMA GROUP S.r.l.
Via Strampelli, 18
63074 San Benedetto del Tronto (AP)
Manufacturers
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Cinarizina + Dimenidrinato Osir
Italy: Agivert