Noclaud

Package Leaflet: Information for the Patient

Noclaud, 100 mg, Tablets

Cilostazol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Noclaud and what is it used for

Noclaud, which contains the active ingredient cilostazol, belongs to a group of medicines called phosphodiesterase type 3 inhibitors. It has various effects, including the dilation of certain blood vessels and the reduction of the activity of blood clotting (aggregation) of certain blood cells, called platelets, within blood vessels.
Noclaud has been prescribed to treat "intermittent claudication". Intermittent claudication is a cramp-like pain in the legs that occurs during walking, which is caused by insufficient blood flow to the legs. Noclaud increases the distance that a patient can walk without pain by improving blood circulation in the legs.
Cilostazol is only recommended for patients in whom lifestyle modifications (including smoking cessation and increased exercise intensity) and other appropriate interventions have not sufficiently alleviated symptoms. It is essential that patients continue to apply lifestyle modifications during cilostazol treatment.

2. Important information before taking Noclaud

When not to take Noclaud

• if you are allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6),
• if you have heart failure,
• if you have resting angina or have had a heart attack or any heart surgery in the last six months,
• if you have ever had a transient ischaemic attack (a temporary reduction in blood flow to the brain) or any other condition that may increase the risk of bleeding or bruising, such as:
• active peptic ulcer,
• stroke or transient ischaemic attack in the last six months,
• diabetic retinopathy,
• uncontrolled hypertension.
• treatment with both acetylsalicylic acid and clopidogrel or any combination of two or more medicines that may increase the risk of bleeding [in case of doubt, consult your doctor or pharmacist],
• severe kidney or moderate to severe liver disease,
• if you are pregnant.

Warnings and precautions

Before taking Noclaud, discuss it with your doctor or pharmacist

• if you have severe heart disease or any heart problems,
• if you have blood pressure problems.

During treatment with Noclaud

• If surgery is required, including dental surgery, inform your doctor or dentist that you are taking Noclaud
• If you notice any signs of bleeding or bruising, stop taking Noclaud and inform your doctor.

Children and adolescents

Noclaud is not intended for use in children.

Noclaud and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to take.
In particular, inform your doctor about taking certain medicines that are usually used to treat pain and/or inflammation of muscles or joints and medicines that reduce blood clotting. These include:

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

If you are taking such medicines together with Noclaud, your doctor may perform certain routine blood tests.
Some medicines taken at the same time as Noclaud may interfere with its effects or increase the risk of side effects. Noclaud may also affect other medicines. Before taking Noclaud, tell your doctor about taking:

• erythromycin, clarithromycin or rifampicin (antibiotics)
• ketoconazole (used to treat fungal infections)
• omeprazole (used to treat increased acidity of stomach juice)
• diltiazem (used to treat high blood pressure or chest pain)
• cisapride (used to treat stomach disorders)
• lovastatin, simvastatin or atorvastatin (used to treat high cholesterol levels in the blood)
• halofantrine (used to treat malaria),
• pimozide (used to treat mental disorders)
• ergot derivatives (used to treat migraines, e.g. ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (used to treat epilepsy)
• St. John's Wort (herbal preparation)

In case of doubt whether the above applies to the medicines you are taking, consult your doctor or pharmacist.
Before taking Noclaud, inform your doctor if you are taking medicines for high blood pressure, as Noclaud may cause additional blood pressure lowering effects. If blood pressure drops too low, it may lead to rapid heartbeat. These medicines include:

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

It may be possible to continue taking these medicines together with Noclaud, and your doctor will be able to decide what treatment is appropriate for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Noclaud MUST NOTbe taken during pregnancy.
Noclaud is NOT RECOMMENDEDfor use in breastfeeding mothers.

Driving and using machines

Noclaud may cause dizziness. If you experience dizziness after taking Noclaud, DO NOTdrive, DO NOTuse tools or machines. Inform your doctor or pharmacist.

3. How to take Noclaud

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose is 2 x 100 mg (two 50 mg tablets or one 100 mg tablet) twice a day (morning and evening). No dose adjustment is necessary in elderly patients. However, your doctor may prescribe a lower dose if you are taking medicines that may affect the action of Noclaud.
• Noclaud should be taken 30 minutes before breakfast and dinner. The tablets should always be swallowed with water.

Some benefits of taking Noclaud may be noticeable after 4-12 weeks of treatment.
Your doctor will assess the effectiveness after 3 months of treatment and may recommend stopping cilostazol treatment if the therapy is not effective enough.

Use in children and adolescents

Noclaud is not intended for use in children.

Taking more Noclaud than prescribed

If you have taken more tablets than prescribed, you may experience symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeat.
If you have taken more tablets than prescribed, contact your doctor or local hospital immediately. Remember to take the package with you to show which medicine you have taken.

Missing a dose of Noclaud

There is no need to worry if you miss a dose. Wait and take the next dose at the right time, and then continue taking the medicine as directed. DO NOTtake a double dose to make up for a missed tablet.

Stopping treatment with Noclaud

If you stop taking Noclaud, the pain in your legs may return or worsen. Therefore, only stop taking Noclaud if you experience side effects that require urgent medical attention (see section 4) or on the advice of your doctor.
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.
If you experience any of the following side effects, you may need urgent medical attention. Stop taking Noclaud and contact your doctor or go to the nearest hospital immediately.

• stroke
• heart attack
• heart problems that may cause shortness of breath or swelling of the ankles
• irregular heartbeat (new or worsening symptom)
• visible bleeding
• easy bruising
• severe skin disease with blisters on the skin, in the mouth, eyes, and genitals
• yellowing of the skin or whites of the eyes due to liver or blood disorders (jaundice)

You should also tell your doctor immediately if you experience fever or sore throat.
It may be necessary to perform certain blood tests, and your doctor will decide on further treatment.

Other side effects of cilostazol have been reported. You should tell your doctor about them as soon as possible:

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

• headache
• abnormal stools
• diarrhea

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

• rapid heartbeat
• palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• discomfort in the abdomen (dyspepsia)
• nausea or vomiting
• loss of appetite (anorexia)
• excessive belching or passing wind (flatulence)
• swelling of the ankles, feet, or face
• rash or skin changes
• itching
• petechiae (small blood spots on the skin)
• general weakness

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

• heart attack
• irregular heartbeat (new or worsening symptom)
• heart problems that may cause shortness of breath or swelling of the ankles
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g. in the stomach, eye, or muscles, nosebleeds, and blood in sputum or urine),
• reduced red blood cell count
• dizziness when standing up
• fainting
• anxiety
• sleep disorders
• nightmares
• allergic reaction
• muscle pain
• diabetes and high blood sugar levels
• stomach pain (gastritis)
• malaise

In people with diabetes, there may be a higher risk of bleeding in the eye.
Rare side effects(may affect up to 1 in 1000 people)

• prolonged bleeding time
• increased platelet count
• kidney problems

The following side effects have been reported during treatment with cilostazol, but the frequency is unknown(frequency cannot be estimated from the available data);

• blood pressure changes
• reduced red blood cell, white blood cell, and platelet count
• breathing difficulties
• mobility problems
• fever
• hot flushes
• rash and other skin changes
• numbness of the skin
• conjunctivitis (discharge or sticky eyes)
• tinnitus (ringing in the ears)
• liver problems, including hepatitis
• changes in urine

If any of the side effects get worse, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Noclaud

The 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 carton. The expiry date refers to the last day of the month.
Do not use this medicine if you notice any visible signs of deterioration (e.g. discoloration).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Noclaud contains

• The active substance is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are: microcrystalline cellulose, maize starch, calcium carmellose, hypromellose 6 cP, and magnesium stearate.

What Noclaud looks like and contents of the pack

Appearance:
Odorless or almost odorless, white or almost white, round, flat tablets with beveled edges. The tablets have a stylized letter E and the number 602 embossed on one side, and no markings on the other side.
Packaging:
28 x (2 x 14), 56 x (4 x 14), or 98 (7 x 14) tablets in PVC/PVDC/Aluminum blisters in a cardboard box with a patient information leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder

EGIS Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest,
Hungary

Manufacturer

EGIS Pharmaceuticals PLC
Bökényföldi út 118-120.
1165 Budapest,
Hungary

The medicinal product is authorized in the Member States of the European Economic Area under the following names:

Hungary Noclaud 100 mg tablet
Czech Republic Noclaud
Latvia Sollazon 100 mg tablets
Lithuania Sollazon 100 mg tabletės
Poland Noclaud
Date of last revision of the leaflet: 03.03.2022