Toliman

Package leaflet: Information for the patient

Toliman 25 mg tablets

Cinnarizine
Please read this leaflet carefully before 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 or pharmacist.
• 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Toliman is and what it is used for

Toliman contains the active substance cinnarizine, which belongs to the class of medicines known as antivertigo agents.
Toliman increases blood flow, thereby delivering more oxygen to tissues, especially to the brain.
Toliman is indicated:

• for the treatment of blood circulation disorders in the brain, particularly those caused by atherosclerosis (accumulation of fats in the arteries)
• as adjunctive therapy in blood vessel diseases (peripheral vascular diseases)
• in balance disorders

2. What you need to know before taking Toliman

Do not take Toliman

• if you are allergic to cinnarizine or to any of the other ingredients of this medicine (listed in section 6, “What Toliman contains”)
• if you suffer from impaired blood flow to the brain (acute cerebral stroke)
• if you are or might be pregnant (see section “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Toliman.
Other medicines and Toliman
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Toliman with food, drinks and alcohol
Take Toliman preferably after meals (see section 3, “How to take Toliman”).
Consumption of alcoholic beverages during treatment with this medicine is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Toliman if you are or might be pregnant.
Driving and using machines
Toliman may affect your ability to drive or operate machinery; therefore, if you experience drowsiness, you must not drive or operate machinery.
Toliman tablets contain:

• lactose – if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
• castor oil – may cause gastrointestinal disturbances and diarrhoea.

3. How to take Toliman

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for cerebral blood circulation disorders and vascular diseases is:
1-2 tablets three times a day.
The recommended dose for balance disorders is: 1 tablet three times a day.
Your doctor may adjust these doses according to your condition.
Maintenance therapy
Even though you may notice a rapid improvement in your symptoms, your doctor may consider it
necessary to prescribe a maintenance therapy to achieve long-lasting results.
Elderly patients
Your doctor will carefully determine the dosage and may consider a possible dose reduction.
If you take more Toliman than you should
If you accidentally take too much Toliman, contact your doctor or go to the nearest hospital
immediately. Appropriate medical care will be provided.
If you forget to take Toliman
Do not take a double dose to make up for the missed dose.
If you stop taking Toliman
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During treatment with Toliman, allergic reactions may occur; in such case, contact your
doctor, who will IMMEDIATELY DISCONTINUE treatment.

Moreover, the following side effects, which are of rare frequency, may occur during treatment:

Effects related to the stomach and intestine:

• Stomach and intestinal disorders

Effects related to the whole body:

• Fatigue

Effects related to the nervous system:

• Drowsiness

P:
During long-term treatment, elderly patients may experience worsening or onset of movement and motor coordination problems (e.g. tremors, muscle spasms, reduced movements).
These phenomena almost always resolve spontaneously within a few months after discontinuation of treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Toliman

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton 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. Package contents and other information

What Toliman contains
One tablet contains:

• The active substance is cinnarizine. Each tablet contains 25 mg of cinnarizine.
• The other components are: lactose (see section "Toliman contains lactose"), starch, dibasic calcium phosphate, hydrogenated castor oil (see section "Toliman contains hydrogenated castor oil"), precipitated silica, talc, magnesium stearate, microcrystalline cellulose, carboxymethylamido.

Description of Toliman and contents of the pack
Toliman tablets are packaged in blisters, in a carton box containing 50 tablets of 25 mg.
Marketing Authorization Holder
SCHARPER S.p.A.
Viale Ortles, 12 – 20139 Milan
Tablet Manufacturer
DOPPEL FARMACEUTICI s.r.l.
Via Volturno, 48 - Quinto Dè Stampi – 20089 Rozzano (Milan)

Patient information leaflet

Toliman 100 mg hard capsules

Cinnarizine
Please read this leaflet carefully before 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 or pharmacist.
• 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Toliman is and what it is used for

Toliman contains the active substance cinnarizine, which belongs to the class of anti-vertigo medicines.
Toliman increases blood flow, thereby delivering more oxygen to tissues, especially to the brain.
Toliman is indicated:

• for the treatment of cerebral blood circulation disorders, particularly those caused by atherosclerosis (accumulation of fats in the arteries)
• as adjunctive therapy in blood vessel diseases (peripheral vascular diseases)
• in balance disorders

2. What you need to know before taking Toliman

Do not take Toliman

• if you are allergic to cinnarizine or to any of the other ingredients of this medicine (listed in section 6 “What Toliman contains”)
• if you suffer from inadequate blood flow to the brain (acute cerebral stroke)
• if you are or might be pregnant (see section “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Toliman.
Other medicines and Toliman
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Toliman with food, drinks and alcohol Take Toliman preferably after meals (see section 3 “How to take Toliman”).
Consumption of alcoholic beverages during treatment with this medicine is not recommended.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Toliman if you are or might be pregnant.
Driving and using machines
Toliman may affect your ability to drive or operate machinery. Therefore, if you experience drowsiness, you must not drive or operate machinery.

3. How to take Toliman

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for cerebral circulation disorders and vascular diseases is:
1 capsule twice daily.
Your doctor may adjust this dose according to your condition.
Maintenance therapy
Even though you may notice a rapid improvement in your symptoms, your doctor may consider it
necessary to prescribe a maintenance therapy to achieve long-lasting results.
Elderly patients
Your doctor will carefully determine the dosage and may consider a possible dose reduction.
If you take more Toliman than you should
If you accidentally take too much Toliman, contact your doctor or go immediately to the nearest
hospital, where you will receive appropriate medical care.
If you forget to take Toliman
Do not take a double dose to make up for the missed dose.
If you stop taking Toliman
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Toliman, allergic reactions may occur; in such case, contact your doctor, who will IMMEDIATELY DISCONTINUE treatment.

Moreover, the following side effects, which are rare, may occur during treatment:

Effects related to the stomach and intestine

• Stomach and intestinal disturbances

Effects related to the whole body

• Fatigue

Effects related to the nervous system

• Drowsiness

P:
During long-term treatments, elderly patients may experience worsening or onset of movement and motor coordination problems (e.g. tremors, muscle spasms, reduced movement).
These phenomena almost always resolve spontaneously within a few months after stopping treatment.

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

5. How to store Toliman

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Toliman contains
Each capsule contains:

• The active substance is cinnarizine. Each capsule contains 100 mg of cinnarizine.
• The other components are: maize starch, talc, magnesium stearate, gelatin, titanium dioxide (E171), indigotine (E132).

Description of the appearance of Toliman and package contents
Toliman is supplied in blister packs of 30 capsules in a carton.
Marketing Authorization Holder
SCHARPER S.p.A.
Viale Ortles, 12 – 20139 Milan
Manufacturer
DOPPEL FARMACEUTICI s.r.l.
Via Volturno, 48 - Quinto Dè Stampi – 20089 Rozzano (Milan)