Noclaud

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Noclaud

100 mg, tablets

Cilostazol

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

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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 type of cramp-like pain in the lower limbs that occurs during walking and is caused by insufficient blood flow to the legs. Noclaud increases the distance that the patient can walk without experiencing pain by improving blood circulation in the lower limbs.
Cilostazol is recommended only for patients who have not had sufficient relief from symptoms after lifestyle modifications (including quitting smoking and increasing exercise intensity) and other appropriate interventions. It is essential that the patient continues to follow the lifestyle modifications during cilostazol treatment.

2. Important information before taking Noclaud

When not to take Noclaud

• if the patient is allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6),
• if heart failure is present,
• if the patient has resting chest pain or has had a "heart attack" or any heart surgery in the last six months,
• if the patient has currently or in the past had transient loss of consciousness due to heart disease or any severe heart rhythm disorders,
• if the patient has been diagnosed with a condition that increases the risk of bleeding or bruising, such as:
• active stomach ulcer,
• stroke in the last six months,
• eye problems due to diabetes,
• uncontrolled high blood pressure.
• 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 a doctor or pharmacist],
• if severe kidney disease or moderate to severe liver disease is present,
• if the patient is pregnant.

Warnings and precautions

Before starting treatment with Noclaud, discuss it with your doctor or pharmacist

• if the patient has severe heart disease or any heart rhythm problems,
• if the patient has high blood pressure problems.

During treatment with Noclaud

• If surgery is required, including tooth extraction, inform the doctor or dentist about the use of Noclaud
• In case of bleeding or bruising, stop taking Noclaud and inform the doctor.

Children and adolescents

Noclaud is not intended for children.

Noclaud and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as 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, as well as medicines that reduce blood clotting. These include:

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

If such medicines are taken together with Noclaud, the doctor may perform certain routine blood tests.
Some concomitantly used medicines may interfere with the action of Noclaud. They may enhance the side effects of Noclaud or reduce its effectiveness. Noclaud may similarly affect other medicines. Before starting treatment with Noclaud, inform your doctor about taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics)
• ketoconazole (used to treat fungal infections)
• omeprazole (used to treat increased stomach acid)
• 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)
• 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 seizures)
• St. John's Wort (herbal preparation)

In case of doubt, whether the above applies to the medicines taken by the patient, consult a doctor or pharmacist.
Before starting treatment with Noclaud, the patient should inform the doctor if they are taking medicines for high blood pressure, as Noclaud may cause additional blood pressure-lowering effects. If excessive blood pressure lowering occurs, it may lead to rapid heart rate. 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 is possible that concomitant use of the above medicines and Noclaud will still be acceptable, and the doctor will be able to decide what treatment is appropriate for the patient.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Noclaud MUST NOTbe used during pregnancy.
IT IS NOT RECOMMENDEDto use Noclaud in breastfeeding mothers.

Driving and using machines

Noclaud may cause dizziness. If dizziness occurs after taking Noclaud, DO NOTdrive vehicles, do not use any tools, or operate any machines. Inform the doctor or pharmacist.

3. How to take Noclaud

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubt, consult a 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 required for elderly patients. However, the doctor may prescribe a lower dose if the patient is taking medicines that may affect the action of Noclaud.
• Noclaud should be taken 30 minutes before breakfast and dinner. Tablets should always be swallowed with water.

Some benefits of taking Noclaud may be noticeable after 4-12 weeks of treatment.
The 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 children.

Using a higher dose of Noclaud than recommended

If the patient has taken more Noclaud tablets than they should, for any reason, they may experience objective and subjective symptoms, such as severe headaches, diarrhea, low blood pressure, and irregular heart rhythm.
In case of taking a higher dose than prescribed, contact a doctor or local hospital immediately. Remember to take the packaging with you, so it is clear what medicine was taken.

Missing a dose of Noclaud

There is no reason to worry if a dose is missed. Wait and take the next dose at the right time, and then take the medicine as instructed. DO NOTtake a double dose to make up for the missed tablet.

Stopping treatment with Noclaud

If treatment with Noclaud is stopped, the pain in the lower limbs may return or worsen. Therefore, stop taking Noclaud only if side effects occur that require urgent medical attention (see section 4) or on the doctor's advice.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Noclaud can cause side effects, although not everybody gets them.
If any of the following side effects occur, urgent medical attention may be necessary. Stop taking Noclaud immediately and contact a doctor or go to the nearest hospital.

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

Inform the doctor immediately if a fever or sore throat occurs.
It may be necessary to perform certain blood tests, and the doctor will decide on further treatment.

Reported side effects of cilostazol

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 heart rate
• heart palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• discomfort in the abdominal area (indigestion)
• nausea or vomiting
• loss of appetite
• excessive gas or belching (bloating with gas)
• 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 heart rhythm (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 muscle, nosebleeds, and blood in sputum or urine),
• reduced red blood cell count
• dizziness when standing up
• fainting
• anxiety
• sleep disturbances
• nightmares
• allergic reaction
• muscle pain
• diabetes and high blood sugar
• stomach pain (gastritis)
• malaise

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

• prolonged bleeding
• increased platelet count
• kidney problems

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

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

If any side effect worsens, inform the doctor or pharmacist.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 or parallel importer.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Noclaud

There are no special storage instructions.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not use this medicine if visible signs of deterioration are observed (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Noclaud contains

• The active substance of Noclaud is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are: microcrystalline cellulose, cornstarch, calcium carmellose, hypromellose 2910, and magnesium stearate.

What Noclaud looks like and what the packaging contains

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, with no markings on the other side.
Packaging:
28 x (2 x 14), 56 x (4 x 14) tablets in PVC/PVDC/Al blisters in a cardboard box with an enclosed patient information leaflet.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Bökényföldi út 118-120.
1165 Budapest
Hungary

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in the Czech Republic, the country of export:83/149/14-C

Parallel import authorization number: 417/24

The medicinal product is registered 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 tablets
Poland
Noclaud

Date of leaflet approval: 27.11.2024

[Information about the trademark]