LASYNAC 200 MG / 30 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist has told you.

• – Keep this leaflet. You may need to read it again.

• – Ask your pharmacist if you need more information or advice.

• – If you get any side effects, talk to your doctor, or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

• – You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

What is in this leaflet

• 1. What Lasynac is and what it is used for

• 2. What you need to know before you take Lasynac

• 3. How to take Lasynac

• 4. Possible side effects

• 5. How to store Lasynac

• 6. Contents of the pack and other information

1. What

2. what you need to know before you take if you are allergic to ibuprofen or pseudoephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warning and precautions

You should discuss your treatment with your doctor or pharmacist before taking Lasynac:

• if you have asthma; use of this drug can cause an asthma attack.
• If you have a history of gastro-intestinal disorders (such as hiatus hernia,

gastrointestinal bleeding, peptic or duodenal ulcer) and chronic inflammatory intestinal disease (ulcerative colitis, Crohn’s disease).

• if you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘ministroke’ or transient ischaemic attack “TIA”).
• if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, of if you are a smoker.
• if you have hyperthyroidism (overactive thyroid gland).
• if you have systemic lupus erythematosus (connective tissue disease), and mixed connective tissue disease, or congenital disorder of porphyrin metabolism.
• if you are taking medicinal drugs interacting with Lasynac, see the list below.
• if you have an infection – please see heading “Infections” below.

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Skin reactions

Serious skin reactions have been reported in association with Lasynac treatment. You should stop taking Lasynac and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

Sudden abdominal pain or rectal bleeding may occur with Lasynac , due to inflammation of the colon (ischemic colitis). If you develop these gastro-intestinal symptoms, stop taking Lasynac and contact your doctor or seek medical attention immediately. See section 4.

If you develop signs of a serious allergic reaction such as: severe skin rashes, peeling, flaking or blistering skin, facial swelling, unexplained wheeziness, shortness of breath, easy bruising, stop taking Lasynac and contact your doctor or seek medical attention immediately. See section 4.

Serious skin reactions have been reported in very rare cases when using a NSAID. Patients seem to be at highest risk early in the course of therapy, the onset of the reaction occurring in the majority of cases in the first month of treatment. Stop taking Lasynac and contact a doctor or seek medical attention immediately if you develop a skin rash or mucous membrane lesions.

Infections

Lasynac may hide signs of infections such as fever and pain. It is therefore possible that Lasynac may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

During a varicella infection (e.g. chicken pox) it is advisable to avoid use of this medicine.

In patients with systemic lupus erythematosus and mixed connective tissue disorders there may be an increased risk of aseptic meningitis or hepatitis.

Prolonged use of any type of painkiller for headaches can make them worse. If you experience frequent or daily headaches despite (or because of) the regular use of headache medications consult your doctor before taking another painkiller. The treatment should be discontinued if medication overuse headache (MOH) is diagnosed.

In case of prolonged treatment with ibuprofen, you should contact your doctor as your liver and kidney function as well as blood picture should be checked regularly.

The habitual intake of painkillers, particularly combination of several pain-relieving medicines, may lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore, it should be avoided.

Reduction of blood flow to your optic nerve may occur with Lasynac. If you develop sudden loss of vision, stop taking Lasynac and contact your doctor or seek medical attention immediately. See section 4.

Interference with blood tests

Pseudoephedrine has the potential to interfere with some diagnostic blood tests. You should tell your doctor that you are taking this medicine if you have a blood test.

Children and adolescents

Lasynac should not be given to children below 15 years.

There is a risk of renal impairment in dehydrated adolescents.

Other medicines and

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Lasynac may affect or be affected by some other medicines. For example:

• – medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl­salicylic acid, warfarin, ticlopidine)

• – medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

Some other medicines may also affect or be affected by the treatment of Lasynac. You should therefore always seek the advice of your doctor or pharmacist before you use Lasynac with other medicines.

In particular tell your doctor or pharmacist if you are taking:

• – antiplatelet drugs and oral anticoagulants (thin blood/prevent clotting e.g. acetylsalicylic acid, warfarin, ticlopidine),

• – other NSAIDs including high dose acetylsalicylic a­cid,

• – cardiac glycosides (eg. digoxin),

• – corticosteroids,

• – injectable heparin,

• – some medicines for depression (e.g.lithium, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase A inhibitors (MAOIs)),

• – methotrexate in high doses (more than 20 mg per week),

• – quinolone antibiotics (used to treat a wide range of infections),

• – ciclosporin, tacrolimus and trimethoprim,

• – medicines for treatment of hypertension (high blood pressure),

• – any anti migraine drugs (including ergot alkaloid derivatives drugs),

• – zidovudine (a medicine for treating HIV/Aids),

• – preparations containing Ginkgo biloba.

• – CYP2C9 inhibitors (e.g., voriconazole, fluconazole),

• – mifepristone (for termination of pregnancy).

Lasynac must not be used in combination with:

• – other vasoconstrictor agents used as nasal decongestants, whether administered orally or nasally (e.g. phenylpropano­lamine, phenylephrine and ephedrine), or methylphenidate,non-selective monoamine oxidase inhibitors (MAOIs) (such as iproniazid), which are prescribed for the treatment of certain depressive disorders.

Due to pseudoephedrine administration an acute hypertensive response may develop in the perioperative period. Therefore, discontinue treatment with Lasynac several days before surgery and inform your anaesthetist.

Lasynac

The film-coated tablets should not be taken with beverages containing alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Lasynac is contraindicated during pregnancy and breastfeeding.

Athletes

Pseudoephedrine hydrochloride can lead to positive results in doping tests.

Driving and using machines

Lasynac could cause dizziness and/or blurred vision and therefore might temporarily affect your ability to drive and use machines.

Lasynac

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This product is for short term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2). Do not take for longer than 5 days unless your doctor tells you to.

The recommended dose is:

Adults and adolescents aged 15 years and older: 1 film-coated tablet every 6 hours if necessary. For more severe symptoms, take 2 film-coated tablets every 6 hours, if necessary.

Never exceed the maximum daily dose of 6 film-coated tablets per day (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride).

The film-coated tablets should be taken without chewing with a glass of water, preferably during meals.

Use in children and adolescents

Lasynac should not be given to children and adolescents below 15 years.

If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

If you take more Lasynac than you should If you have taken more Lasynac than you should, or if children have taken medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

4. possible side effects

Like all medicines, Lasynac can cause side effects, although not everybody gets them.

Stop taking Lasynac immediately and consult a doctor immediately if you experience:

• Signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds.
• Signs of a serious allergic reaction such as: severe skin rashes, peeling, flaking or blistering skin, facial swelling, unexplained wheeziness, shortness of breath, easy bruising.
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

Frequency “Not known”

• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
• Inflammation of the colon due to insufficient blood supply (ischemic colitis)
• Reduced blood flow to the optic nerve (ischemic optic neuropathy)

Stop using Lasynac if you develop these symptoms and seek medical attention immediately. See also section 2.

Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed.

Common (affects 1 to 10 users in 100)

• indigestion, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation

Uncommon (affects 1 to 10 users in 1,000)

• Headache, dizziness, tiredness, difficulty in sleeping, agitation, irritability or tiredness
• Visual impairment
• Stomach or intestinal ulcers, sometimes with bleeding and perforation, worsening of colitis and Crohn's disease
• Skin rashes

Rare (affects 1 to 10 users in 10,000)

• Tinnitus (ringing in the ears)
• Kidney damage

Very rare (affects less than 1 user in 10,000)

• Problems in blood cell production that might make you bruise more easily or make you more susceptible to infections
• Severe allergic reactions
• Psychotic reactions and depression
• High blood pressure, palpitations, heart attack
• Inflammation of the blood vessels (vasculitis)
• Liver damage
• Severe skin reactions
• Kidney damage, or difficulty passing urine

Not known (frequency cannot be estimated from the available data)

Increased sensitivity of the skin to sun

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at:or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or the blister after (EXP). The expiry date refers to the last day of the month.

Store below 25°C.

Store in the original package. Keep blister in the outer cartoon.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help you protect the environment.

6. contents of the packs and other information- the active substances are ibuprofen 200 mg and pseudoephedrine hydrochloride 30mg.

• – The other ingredients are:

What

Lasynac are round, white, film-coated tablets.

One pack contains 10 or 20 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sanofi

410 Thames Valley Park Drive

Reading, Berkshire RG6 1PT

United Kingdom

Tel: 0800 035 2525

Email:

Manufacturer:

Przedsiebiorstwo Produkcji Farmaceutycznej Hasco – Lek,

Zmigrodzka 242 E, 51–131 Wroclaw, Poland

This medicinal product is authorised in the Member States of the EEA under the

This leaflet was last revised in July 2020