Noclaud

Package leaflet: Information for the patient

Warning! Keep the leaflet – the packaging information is in a foreign language.
Noclaud
100 mg, tablets
Cilostazol
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Noclaud is and what it is 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 Noclaud is and what it is used for

Noclaud contains the active ingredient cilostazol and belongs to a group of medicines known as phosphodiesterase type 3 inhibitors. It produces various effects, including dilation of certain blood vessels and reduction of clotting (aggregation) activity of certain blood cells called platelets within blood vessels.

Noclaud has been prescribed for the treatment of "intermittent claudication". Intermittent claudication is a cramp-like pain in the lower limbs occurring during walking, caused by inadequate blood flow to the legs. Noclaud increases the distance a patient can walk without experiencing pain by improving blood circulation in the lower limbs.

Cilostazol is recommended only for patients in whom lifestyle modifications (including smoking cessation and increased exercise) and other appropriate interventions have not sufficiently alleviated symptoms. It is important that the patient continues to adhere to these lifestyle modifications during treatment with cilostazol.

2. Important information before using Noclaud

When not to use Noclaud

• if the patient is allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has heart failure,
• if the patient has chest pain at rest or has had a heart attack or any heart surgery within the last six months,
• if the patient has currently or previously experienced a brief 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 peptic ulcer,
• stroke within the last six months,
• diabetic eye disease,
• poorly controlled 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 the patient has severe kidney disease or moderate to severe liver disease,
• if the patient is pregnant.

Warnings and precautions
Before starting treatment with Noclaud, discuss with your doctor or pharmacist:

• if the patient has severe heart disease or any heart-related problems,
• if the patient has blood pressure problems.

During treatment with Noclaud:

• If surgery is required, including tooth extraction, inform the doctor or dentist that you are taking Noclaud.
• If you notice a tendency to bruise easily or to bleed, stop taking Noclaud and inform your doctor immediately.

Children and adolescents
Noclaud is not intended for use in children.
Noclaud with 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 if you are taking certain medicines commonly used to treat
pain and (or) muscle or joint inflammation, and medicines that reduce blood clotting. These include:

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

If these medicines are taken together with Noclaud, your doctor may perform certain routine blood tests.
Some concomitant medicines may interfere with the action of Noclaud. They may increase the
adverse effects of Noclaud or reduce its effectiveness. Noclaud may similarly affect other medicines.
Before starting Noclaud, inform your doctor if you are 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 for stomach disorders)
• lovastatin, simvastatin or atorvastatin (used to treat high blood cholesterol)
• halofantrine (used to treat malaria)
• pimozide (used to treat psychiatric disorders)
• ergot derivatives (used to treat migraine, e.g. ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (used to treat seizures)
• St John's wort (herbal remedy)

If you are unsure whether any of the above applies to medicines you are taking, consult your doctor or pharmacist.
Before starting Noclaud, the patient should inform the doctor if they are taking medicines for high blood pressure, because Noclaud may produce an additional blood pressure-lowering effect. If blood pressure drops too much, it may lead to a 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 still be acceptable to use the above-mentioned medicines together with Noclaud; your doctor will decide which treatment is appropriate for you.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Noclaud MUST NOT be used during pregnancy.
Noclaud is NOT RECOMMENDED for use in breastfeeding mothers.
Driving and operating machinery
Noclaud may cause dizziness. If dizziness occurs after taking Noclaud, DO NOT drive, operate tools, or use any machinery. Inform your doctor or pharmacist.

3. How to take Noclaud

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Noclaud is available in the following strengths: 50 mg, 100 mg.

• The recommended dose is 2 x 100 mg (two 50 mg tablets or one 100 mg tablet) twice daily (morning and evening). Dose adjustment is not required in 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 taken with water.

Some benefits of using Noclaud may become noticeable after 4–12 weeks of treatment.
The doctor will assess treatment efficacy after 3 months and may recommend discontinuation of treatment with cylostazol
if the therapeutic response is inadequate.
Use in children and adolescents
Noclaud is not intended for use in children.
Taking more Noclaud than recommended
If for any reason a patient has taken more Noclaud tablets than prescribed, adverse symptoms
may occur, such as severe headaches, diarrhoea, low blood pressure, and arrhythmia.
In case of overdose, contact a doctor or the nearest hospital immediately. Remember to bring
the packaging along to clearly identify which medicine has been taken.
Missing a dose of Noclaud
There is no cause for concern if a dose is missed. Wait and take the next dose at the scheduled time, then continue taking the medicine as directed. DO NOT take a double dose to make up for a missed tablet.
Stopping Noclaud
If treatment with Noclaud is discontinued, leg pain may return or worsen. Therefore, Noclaud should only be discontinued if adverse reactions occur that require urgent medical attention (see section 4) or as directed by a doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
If any of the symptoms listed below occur, urgent medical attention may be required.
You must immediately stop taking Noclaud and contact your doctor or go to the nearest hospital.

• stroke
• heart attack
• heart problems which may cause shortness of breath or ankle swelling
• irregular heartbeat (new or worsening symptom)
• noticeable bleeding
• easy bruising
• severe blistering illness affecting the skin, mouth, eyes, and genitals
• yellowing of the skin or whites of the eyes due to liver or blood disorders (jaundice)

You should also immediately inform your doctor if you develop fever or sore throat.
Blood tests may be necessary, and your doctor will decide on further treatment.
The following adverse reactions of cilostazol have been reported.
You should inform your doctor as soon as possible if any of these occur:

Very common adverse reactions
(may affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhoea

Common adverse reactions
(may affect up to 1 in 10 people)

• fast heartbeat
• palpitations
• chest pain
• dizziness
• sore throat
• cold symptoms (nasal catarrh)
• abdominal pain
• gastrointestinal discomfort (dyspepsia)
• nausea or vomiting
• loss of appetite (anorexia)
• excessive burping or passing wind (bloating with flatulence)
• swelling of ankles, feet, or face
• skin rash or skin changes
• itching of the skin
• petechial skin bleeding (small red or purple spots due to bleeding under the skin)
• general weakness

Uncommon adverse reactions
(may affect up to 1 in 100 people)

• heart attack
• irregular heart function (new or worsening symptom)
• heart disorders causing shortness of breath or swelling of the ankles
• lung inflammation
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g. in the stomach, eye, or muscles, nosebleeds, blood in sputum or urine)
• decreased number of red blood cells in blood
• dizziness upon standing
• fainting
• anxiety
• sleep disturbances
• nightmares
• allergic reaction
• muscle pain and tenderness
• diabetes and elevated blood glucose levels
• stomach pain (gastritis)
• malaise

In patients with diabetes, there may be an increased risk of bleeding into the eye.

Rare adverse reactions
(may affect up to 1 in 1,000 people)

• tendency to bleed longer than normal
• increased number of platelets in blood
• kidney problems

The following adverse reactions have been reported during treatment with cilostazol, but the frequency is unknown
(frequency cannot be estimated from the available data):

• changes in blood pressure
• decreased number of red blood cells, white blood cells, and platelets in blood
• difficulty breathing
• difficulty with movement
• fever
• hot flushes
• rash and other skin eruptions
• reduced skin sensation
• watery or sticky eye discharge (conjunctivitis)
• tinnitus (ringing in the ears)
• liver problems, including hepatitis
• changes in urine

If any of the adverse reactions worsen, you should inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Noclaud

No special storage conditions required.
Keep this 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 stated month.
Do not use this medicine if you notice any visible signs of deterioration (e.g. discolouration).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Noclaud contains

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

What Noclaud looks like and contents of the pack
Appearance: Odourless or almost odourless, white or almost white, round, flat tablets with bevelled edges. The tablets have a stylised letter "E" and the number "602" embossed on one side, with no marking on the other side.
Pack: 56 tablets in PVC/PVDC//Al blisters, packed in a cardboard box with an enclosed patient information leaflet.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Hungary, the country of export:
Egis Gyógyszergyár Zrt.
Keresztúri út 30-38.
H-1106 Budapest
Hungary
Manufacturer:
Egis Gyógyszergyár Zrt.
Bökényföldi út 118-120.
H-1165 Budapest
Hungary
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Hungarian Marketing Authorisation Number in the country of export: OGYI-T-22586/04
Parallel import authorisation number: 418/19
The medicinal product is authorised in the Member States of the European Economic Area under the following names:
Hungary Noclaud 100 mg tabletta
Czech Republic Noclaud
Latvia Sollazon 100 mg tabletes
Lithuania Sollazon 100 mg tabletės
Poland Noclaud