ALBATEN 100 mg Tablets

Зміст інструкції

1. Albaten 100 mg tablets
   1. What is Albaten and what is it used for
   2. What you need to know before taking Albaten
   3. How to take Albaten
   4. Possible side effects
   5. How to store Albaten
   6. Package Contents and Other Information

Albaten 100 mg tablets

cilostazol
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Albaten and what is it used for

Albaten belongs to a group of medicines called phosphodiesterase type 3 inhibitors.
It works in various ways, including dilating some blood vessels and reducing the coagulation activity of
some blood cells called platelets inside the blood vessels.
Albaten has been prescribed for “intermittent claudication”. Intermittent claudication is the
pain, similar to a cramp, that you feel in your legs when walking, and is caused by an insufficient supply of
blood to the legs. Albaten, by improving blood circulation in the legs, allows you to walk without feeling pain for a longer distance. Albaten is recommended
only for patients whose symptoms have not improved sufficiently after modifying their lifestyle (e.g. quitting smoking and doing more physical activity) and after taking other measures. It
is important that you continue to follow the changes you have made to your lifestyle while taking
Albaten.

2. What you need to know before taking Albaten

Do not take Albaten:

• if you are allergic (hypersensitive) to cilostazol or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a condition called “heart failure”
• if you experience persistent chest pain when at rest, or if you have had a “heart attack” or any heart surgery in the last six months
• if you suffer from or have suffered in the past from fainting caused by a heart condition, or from severe heart rhythm disturbances
• if you know you have a condition that increases the risk of bleeding or bruising, such as:
• one or more active stomach ulcers.
• a stroke that occurred in the last six months.
• eye problems if you suffer from diabetes.
• if your blood pressure is not well controlled
• if you have a severe kidney disease or a severe or moderate liver disease
• if you are taking both acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that can increase the risk of bleeding [if you have doubts, consult your doctor or pharmacist]
• if you are pregnant.

Warnings and precautions
Before taking Albaten, make sure you inform your doctor:

• if you have a serious heart problem, or any problems with your heart rhythm.
• if you have blood pressure problems.

During treatment with Albaten, make sure:

• if you have to undergo surgery, including a tooth extraction, to inform your doctor or dentist that you are taking Albaten.
• if you bruise or bleed easily, to stop taking Albaten and to inform your doctor.

Other medicines and Albaten
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Before taking Albaten, inform your doctor specifically if you are taking some medicines commonly used
for painful and/or inflammatory conditions of the muscles or joints, or if
you are taking medicines that reduce blood clotting. These medicines include:

• acetylsalicylic acid
• clopidogrel
• anticoagulants (e.g. warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparins).

If you are taking these medicines together with Albaten, your doctor may subject you to some routine
blood tests.
Some medicines can interfere with the effect of Albaten if they are taken at the same time.
They may increase the undesirable effects of Albaten, or reduce the effectiveness of Albaten. Albaten may
do the same for other medicines. Before starting to take Cilostazol, tell your doctor
if you are taking:

• erythromycin, clarithromycin or rifampicin (antibiotics)
• ketoconazole (for the treatment of fungal infections)
• protease inhibitors (antivirals)
• omeprazole (for the treatment of excessive stomach acidity)
• diltiazem (for high blood pressure or chest pain)
• cisapride (for the treatment of stomach disorders)
• lovastatin, simvastatin or atorvastatin (for high cholesterol levels in the blood)
• halofantrine (for the treatment of malaria)
• pimozide (for the treatment of mental illnesses)
• ergot derivatives (for migraine, e.g. ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (for the treatment of seizures)
• St. John's Wort (herbal medicine).

If you have any doubts about the validity of the above for the medicines you are taking, ask your doctor or
pharmacist.
Before taking Albaten, tell your doctor if you are taking medicines for high blood pressure
(hypertension), as Albaten may enhance the blood pressure lowering effect. If your blood pressure drops too low, your heart rate may increase. These medicines
include:

• diuretics (e.g. hydrochlorothiazide, furosemide)
• calcium antagonists (e.g. verapamil, amlodipine)
• ACE inhibitors (e.g. captopril, lisinopril)
• angiotensin II receptor antagonists (e.g. valsartan, candesartan)
• beta-blockers (e.g. labetalol, carvedilol);

It may still be possible to take the above medicines together with Albaten and your doctor
will be able to decide what is appropriate in your case.

Albaten with food, drinks and alcohol
Albaten tablets should be taken 30 minutes before breakfast and dinner.
Always take the tablets with water.

Pregnancy and breastfeeding
Albaten MUST NOTbe used during pregnancy.
For women who are breastfeeding, the use of Albaten is NOT RECOMMENDED.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Albaten can cause dizziness. If you experience dizziness after taking Albaten tablets, DO NOT
drive vehicles and do not use tools or machinery, and inform your doctor or pharmacist.

3. How to take Albaten

• Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or pharmacist.
• The recommended dose is one 100 mg tablet twice a day (morning and evening). This dose does not require adjustments for elderly people. However, your doctor may prescribe a lower dose if you are taking other medicines that may interfere with the effect of Albaten.
• Albaten tablets must be taken 30 minutes before breakfast and dinner. Always take the tablets with water.

You may feel the benefits of taking Albaten within 4-12 weeks of treatment. The doctor
will assess your progress after 3 months of treatment and may recommend you to stop taking the
Albaten if the effect of the treatment is insufficient.

Albaten is not suitable for children.

If you take more Albaten than you should
If for any reason you have taken more Albaten tablets than you should, you may have
signs and symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeat.

If you have taken more tablets than your prescribed dose, contact your doctor or
the nearest hospital immediately. Remember to bring the medicine packaging with you, so that
it is clear what you have taken.
If you forget to take Albaten
If you miss a dose, do not worry; wait until the time of the next dose and take the
next tablet, then continue normally. DO NOTtake a double dose to make up for the
missed tablet.

If you stop taking Albaten
If you stop taking Albaten, leg pain may return or worsen. Therefore, stop taking Albaten only if you notice side effects that require urgent medical attention (see
paragraph 4), or if your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

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

If you experience any of the following side effects, you may need urgent
medical attention. Stop taking Albaten and contact your doctor immediately or go to the
nearest hospital.

• allergic reactions
• stroke
• heart attack
• heart problems that can cause shortness of breath or swelling of the ankles
• irregular heartbeat (new or worsening)
• significant bleeding
• easy bruising
• severe illness with blistering of the skin, mouth, eyes and genitals
• yellowing of the skin or the whites of the eyes, due to problems with the liver or blood (jaundice)

Tell your doctor immediately if you have a fever or sore throat. Some blood tests may be necessary
before restarting treatment.

The following effects have been reported for Albaten. Tell your doctor as soon as possible:

Very common side effects(may affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhoea

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

• fast heartbeat
• strong heartbeat (palpitations)
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• abdominal discomfort (indigestion)
• nausea or vomiting
• loss of appetite (anorexia)
• excessive belching or flatulence
• swelling of the ankles, feet or face
• skin rash or changes in skin appearance
• itchy skin
• pinpoint bleeding under the skin
• feeling of general weakness

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

• heart attack
• irregular heartbeat (new or worsening)
• heart problems that can cause shortness of breath or swelling of the ankles
• pneumonia
• cough
• chills
• unexplained bleeding
• tendency to bleed (for example from the stomach, eyes or muscles, blood from the nose and presence of blood in the saliva or urine)
• decreased number of red blood cells in the blood
• dizziness when standing up
• fainting
• feeling of anxiety
• insomnia
• unusual dreams
• allergic reaction
• generalized pain
• diabetes and increased blood sugar
• stomach pain (gastritis)
• feeling unwell.

In people with diabetes, the risk of bleeding inside the eye may increase.

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

• tendency to bleed for longer than usual
• increased number of platelets in the blood
• kidney problems

Side effects with unknown frequency(frequency cannot be estimated on the basis of the available
data):

• changes in blood pressure
• decreased number of red blood cells, white blood cells and platelets in the blood
• difficulty breathing
• movement difficulties
• fever
• hot flushes
• eczema and other skin rashes
• reduced skin sensitivity
• watery or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system at
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 Albaten

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 package and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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

• The active ingredient is cilostazol. Each tablet contains 100 mg of cilostazol
• The other ingredients are corn starch, microcrystalline cellulose, calcium carmellose, hypromellose and magnesium stearate.

Description of the appearance of Albaten and package contents
Albaten 100 mg tablets are white, round tablets, with an incision line on one side, with an
approximate diameter of 8 mm.
The medicine is supplied in packs of 28 tablets, in PCV/aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S&R Farmaceutici S.p.A
Via dei Pioppi, 2
06083 Bastia Umbra (PG)
Italy
Manufacturer

• J. Uriach y Compañía S.A. Polígon Industrial Riera de Caldes Avinguda Camí Reial 51-57 08184 Palau-solità i Plegamans (Barcelona-Spain)

Galenicum Health, S.L.
Avda. Diagonal 123, Planta 11

• 08005 – Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: Albaten