Aceclofenac holsten

Package leaflet: Information for the patient

Aceclofenac Holsten, 100 mg, coated tablets
Aceclofenacum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Aceclofenac Holsten is and what it is used for

Aceclofenac Holsten is an analgesic and anti-inflammatory medicine.
Aceclofenac Holsten is used in adults to treat chronic joint diseases associated with persistent pain and inflammation, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

2. Important information before using Aceclofenac Holsten

When not to use Aceclofenac Holsten

• if the patient is allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6),
• if the patient is in the last three months of pregnancy,
• if the patient has previously experienced asthma, acute inflammation of the nasal mucosa, skin rash, or other allergic reactions after taking acetylsalicylic acid (e.g. aspirin) or another non-steroidal anti-inflammatory drug,
• if the patient currently has or has previously had stomach or intestinal ulcers or gastrointestinal bleeding, whether related or unrelated to previous treatment with NSAIDs,
• if the patient has active bleeding or bleeding disorders,
• if the patient has severe liver or kidney impairment,
• if the patient has heart disease and/or cerebrovascular disease, e.g. following myocardial infarction, stroke, or arterial embolism in the heart or brain, or following a procedure to unblock or bypass blocked blood vessels,
• if the patient currently has or has previously had circulatory disorders (peripheral vascular disease).

Warnings and precautions
Before starting treatment with Aceclofenac Holsten, discuss this with your doctor.

• if the patient has previously experienced symptoms of gastric or duodenal ulcers, bleeding or perforation, or inflammatory bowel diseases (ulcerative colitis, Crohn's disease), as these may worsen,
• if the patient has a history of cerebral haemorrhage,
• if the patient has moderate liver or kidney disease or a tendency to fluid retention for any other reason,
• if the patient has coagulation disorders, as these may worsen,
• if the patient has a specific skin and connective tissue disorder, so-called SLE (systemic lupus erythematosus),
• if the patient has a specific metabolic disorder, so-called porphyria,
• if the patient has previously had or still has bronchial asthma,
• if the patient smokes,
• if the patient has diabetes,
• if the patient has angina pectoris, thrombosis, hypertension, or elevated cholesterol levels.

Use of medicines such as Aceclofenac Holsten may be associated with an increased risk of heart attack (myocardial infarction). The occurrence of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary. Do not increase the recommended dose or extend the duration of treatment. Hypersensitivity reactions, including angioedema and severe skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported with the use of Aceclofenac Holsten. The risk of skin reactions is higher during the first month of treatment. At the first sign of skin rash, mucosal damage, or any symptoms of hypersensitivity, treatment must be discontinued and the doctor must be informed immediately (see section 4).
Treatment with Aceclofenac Holsten must be discontinued at the first appearance of skin rash or other symptoms of hypersensitivity. Aceclofenac Holsten should not be used in cases of chickenpox.
Aceclofenac Holsten may rarely cause gastrointestinal ulcers and bleeding. This may occur at any time during treatment, with or without warning symptoms.
If any gastrointestinal symptoms occur, especially in elderly patients, contact a doctor immediately.

Aceclofenac Holsten and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of Aceclofenac Holsten. In such cases, it may be necessary to adjust the dose or discontinue treatment. This is particularly important if the patient is taking:

• acetylsalicylic acid and other painkillers (so-called non-steroidal anti-inflammatory drugs),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• diuretics (water tablets),
• cardiac glycosides such as digoxin (used in the treatment of heart failure or cardiac arrhythmias),
• lithium (used in the treatment of psychiatric disorders),
• methotrexate (used in the treatment of tumors and rheumatism),
• corticosteroids,
• anticoagulants (blood thinners),
• quinolone antibiotics,
• medicines used to treat depression,
• cyclosporine and tacrolimus (immunosuppressive medicines used to prevent rejection of transplanted organs),
• zidovudine (used in the treatment of HIV infection),
• antidiabetic medicines.

Taking Aceclofenac Holsten with food and drink
Aceclofenac Holsten can be taken with food.
Pregnancy, breastfeeding and fertility
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.
Inform your doctor if you are planning pregnancy or if you have difficulty becoming pregnant.
Use of aceclofenac may impair fertility in women and thus make it more difficult to become pregnant.
Aceclofenac Holsten must not be used if the patient is in the third trimester of pregnancy, as the medicine may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both the mother and the child and may delay or prolong labour. Aceclofenac Holsten should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. If use during this period or when planning pregnancy is required, the lowest possible dose should be used for the shortest possible time. Aceclofenac Holsten used for longer than a few days beyond the 20th week of pregnancy may cause kidney dysfunction in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is required for longer than a few days, the doctor may recommend additional monitoring tests.
It is not known whether Aceclofenac Holsten passes into breast milk. Use during breastfeeding is not recommended unless otherwise decided by the doctor.

Driving and operating machinery
Do not drive or operate machinery if dizziness or other central nervous system disturbances occur during treatment with Aceclofenac Holsten.

Aceclofenac Holsten contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium in one coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Aceclofenac Holsten

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Tablets should be swallowed whole, with an adequate amount of liquid (at least half a glass
of water or another drink).
The recommended daily dose is 200 mg, administered in two divided doses of 100 mg each,
one tablet in the morning and one in the evening.
If you feel that the effect of Aceclofenac Holsten is too strong or too weak, consult your doctor
or pharmacist.
Use in children and adolescents
Aceclofenac Holsten is not recommended for use in children and adolescents under 18 years of age
due to lack of data on efficacy and safety.
Elderly patients
Dose reduction is usually not required. However, as a precaution, the doctor should determine
the dosage.
Kidney disease
Dosage will be determined by the doctor.
Liver disease
The recommended initial daily dose should be reduced to one coated tablet per day.
Long-term treatment
During long-term use of Aceclofenac Holsten, the doctor will perform regular laboratory tests
(blood count, liver and kidney function tests) at periodic intervals.
Taking more Aceclofenac Holsten than recommended
Seek immediate medical advice from a doctor or pharmacist, or go to the nearest hospital emergency department.
Bring this leaflet with you.
If you miss a dose of Aceclofenac Holsten
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
Stopping Aceclofenac Holsten
The duration of treatment is determined by the doctor. Do not stop treatment prematurely, even
if you feel better.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Most of them are mild and resolve after discontinuation of Aceclofenac Holsten.
Aceclofenac Holsten must be stopped immediately and medical help sought if the patient experiences:
Allergic reactions, including anaphylactic shock and angioedema (rare), with symptoms such as:

• swelling of the face, tongue or throat,
• difficulty swallowing,
• urticaria and breathing difficulties,
• drop in blood pressure and fever.

Gastrointestinal ulcers and bleeding (rare), with symptoms such as:

• bloody stools (very rare),
• black, tarry stools (rare),
• vomiting blood or dark particles resembling coffee grounds (very rare).

Potentially life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), with symptoms such as:

• itching, rash, redness, inflammation, pain and formation of blisters.

Other adverse reactions:
Common (may occur in up to 1 in 10 people):
dizziness, dyspepsia (indigestion), abdominal pain, nausea, diarrhoea and changes in liver function tests.
Uncommon (may occur in up to 1 in 100 people): flatulence, gastritis (inflammation of the stomach lining), constipation, vomiting, oral ulceration, skin itching, rash, dermatitis, urticaria, renal function disorders.
Rare (may occur in up to 1 in 1,000 people): anaemia (low red blood cell count or low haemoglobin concentration), visual disturbances, heart failure, hypertension, dyspnoea (difficulty breathing or shortness of breath).
Very rare (may occur in up to 1 in 10,000 people): abnormally low white blood cell and platelet counts, haemolytic anaemia, elevated potassium levels, depression, sleep disorders (nightmares, insomnia), paraesthesia (tingling sensations), tremors (rhythmic, involuntary movements), headache, taste disturbances, somnolence, dizziness (spinning sensation), tinnitus (ringing, buzzing or other sounds in the ears without external cause), palpitations (uncomfortable sensation of irregular and/or strong heartbeat), sudden reddening of the face, sudden hot flushes, vasculitis (inflammation of blood vessels), breathing difficulties (bronchospasm), stomatitis (inflammation of the mucous membrane of the mouth), intestinal perforation, exacerbation of inflammatory gastrointestinal disorders (Crohn's disease, ulcerative colitis), pancreatitis, haematemesis (vomiting blood), liver damage (including hepatitis), jaundice, increased liver enzyme activity in blood, purpura (numerous small skin haemorrhages), rash, acute mucocutaneous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis), renal failure, renal function disorders, oedema (swelling of legs, arms or face), leg muscle cramps, fatigue, weight gain.

In isolated cases during chickenpox, severe skin or soft tissue infections have been observed.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aceclofenac Holsten

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
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 the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Aceclofenac Holsten contains
The active substance in Aceclofenac Holsten is aceclofenac.
Each coated tablet contains 100 mg of aceclofenac.
Other ingredients are:
microcrystalline cellulose, sodium croscarmellose, copovidone (K28), talc, colloidal anhydrous silica,
glycerol distearate (type I).
Coating Opadry 03A0280002: hypromellose type 2910, titanium dioxide (E 171), microcrystalline cellulose,
polyethylene glycol stearate (type I).
What Aceclofenac Holsten looks like and contents of the pack
White, round, biconvex coated tablets with a diameter of 8 mm.
Blister OPA/Aluminium/PVC/Aluminium in a cardboard box.
Pack sizes: 20, 30, 40, 50, 60, 70, 80, 90, 100 or 180 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Holsten Pharma GmbH
Hahnstrasse 31-35
60528 Frankfurt am Main
Germany
E-mail: [email protected]
For further information on this medicinal product, please contact the Marketing Authorisation Holder.