Albaten

Package leaflet: Information for the user

Albaten 100 mg tablets

cilostazol
Equivalent medicine
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, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 Albaten is and what it is used for

Albaten belongs to a group of medicines called type 3 phosphodiesterase inhibitors.
It works in several ways, including by dilating certain blood vessels and reducing the clotting activity of
certain blood cells called platelets within the blood vessels.
Albaten has been prescribed to you for "intermittent claudication". Intermittent claudication is the
cramp-like pain you feel in your legs when walking, caused by insufficient blood supply to the legs. By
improving blood circulation in the legs, Albaten enables you to walk longer distances without pain. Albaten is recommended
only for patients whose symptoms have not sufficiently improved after lifestyle modifications (such as quitting smoking and increasing physical activity) and other measures. It is important that you continue to maintain the lifestyle changes you have made while taking Albaten.

2. What you need to know before taking Albaten

Do not take Albaten:

• if you are allergic (hypersensitive) to cilostazol or to any of the other ingredients of this medicine (listed in section 6)
• if you have a condition called "heart failure"
• if you experience persistent chest pain at rest, or if you have had a "heart attack" or any heart surgery within the last six months
• if you currently have or have previously had fainting episodes due to heart disease, or serious heart rhythm disorders
• if you know you have a condition that increases the risk of bleeding or bruising, for example:
• one or more active stomach ulcers
• a stroke that occurred within the last six months
• eye problems if you have diabetes
• if your blood pressure is not well controlled
• if you have severe kidney disease or severe or moderate liver disease
• if you are taking both acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that may increase the risk of bleeding [if in doubt, consult your doctor or pharmacist]
• if you are pregnant.

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

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

While being treated with Albaten, ensure that:

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

Other medicines and Albaten
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking Albaten, specifically inform your doctor if you are taking certain medicines commonly used for painful and/or inflammatory conditions affecting 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 perform some routine blood tests.
Some medicines may interfere with the effect of Albaten when taken at the same time. They may increase the side effects of Albaten, or reduce its effectiveness. Albaten may also have similar effects on other medicines. Before starting to take Cilostazol, inform your doctor if you are taking:

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

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

• diuretics (e.g. hydrochlorothiazide, furosemide)
• calcium channel blockers (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 medicines listed above together with Albaten, and your doctor will decide what is appropriate for your individual 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 NOT be used during pregnancy.
For women who are breastfeeding, the use of Albaten IS NOT RECOMMENDED.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Albaten may cause dizziness. If you experience dizziness after taking Albaten tablets, DO NOT drive or operate tools or machinery, and inform your doctor or pharmacist.

3. How to take Albaten

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

You may start experiencing the benefits of Albaten within 4–12 weeks of treatment. Your doctor will assess your progress after 3 months of treatment and may advise you to stop taking Albaten if the treatment effect is insufficient.
Albaten is not suitable for children.
If you take more Albaten than you should
If you have taken more Albaten tablets than prescribed for any reason, you may experience signs and symptoms such as severe headache, diarrhoea, 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 package 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 for your next dose and take it as scheduled, then continue as normal. DO NOT take 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 experience side effects requiring urgent medical attention (see section 4), or if your doctor tells you to do so.
If you have any questions about the use of this medicine, consult 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, urgent medical attention may be required.
Stop taking Albaten and contact a doctor immediately or go to the nearest hospital.

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

Contact your doctor immediately if you have fever or a sore throat. Blood tests may be required before restarting treatment.
The following side effects have been reported with Albaten. Inform 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)

• rapid heartbeat
• strong or forceful heartbeats (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
• patchy 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 may cause shortness of breath or swelling of the ankles
• pneumonia
• cough
• chills
• unexplained bleeding
• tendency to bleed (e.g. in the stomach, eyes, or muscles, nosebleeds, blood in saliva or urine)
• reduced 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 levels
• stomach pain (gastritis)
• malaise

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 longer than usual
• increased number of platelets in the blood
• kidney problems

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• changes in blood pressure
• reduced number of red blood cells, white blood cells, and platelets in the blood
• breathing difficulties
• motor 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 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 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 stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Albaten contains

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

Description of the appearance of Albaten and contents of the pack
Albaten 100 mg tablets are white, round tablets, with a score line on one side, approximately 8 mm in diameter.
The medicine is supplied in packs of 28 tablets in PVC/aluminum 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

Manufacturers
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 European Economic Area countries under the
following names:
Italy: Albaten