Spedifen 200mg 20 tablets

In this manual :

1. WHAT IS SPEDIFEN 200 mg, tablet AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE TAKING SPEDIFEN 200 mg, Tablet

3. HOW DO I TAKE SPEDIFEN 200 mg, tablet?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW DO I USE SPEDIFEN 200 mg, tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS SPEDIFEN 200 mg, tablet AND WHAT IS IT USED FOR?

OTHER ANALGESICS AND ANTIPYRETICS

This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. It is indicated in adults and children over 20 kg (approximately 6 years of age) for the short-term treatment of fever and/or pain such as headaches, flu-like conditions, dental pain, aches and pains and painful periods.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SPEDIFEN 200 mg, tablet

Not applicable.

Never take SPEDIFEN 200 mg, tablet in the following cases:

• after 5 months of pregnancy (24 weeks of amenorrhea),
• a history of allergy or asthma triggered by this or a related medication, including other nonsteroidal anti-inflammatory drugs, acetylsalicylic acid (aspirin)
• history of allergy to other components of the tablet,
• history of gastrointestinal bleeding or ulcers from previous NSAID therapy,
• active or recurrent ulcer or bleeding from the stomach or intestine,
• ongoing gastrointestinal hemorrhage, brain hemorrhage or other bleeding,
• severe liver disease,
• severe kidney disease,
• severe heart disease,
• systemic lupus erythematosus,
• children under 6 years of age because they may swallow incorrectly and choke.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.

Take special precautions with SPEDIFEN 200 mg, tablet:

At high doses, greater than 1200 mg/day, this drug has anti-inflammatory properties and may cause the sometimes serious side effects seen with non-steroidal anti-inflammatory drugs.

Drugs such as SPEDIFEN 200 mg, tablet may increase the risk of heart attack ("myocardial infarction") or stroke. The higher the dose and the longer the duration of treatment, the greater the risk.

Do not exceed the recommended doses or duration of treatment.

If you have heart problems, have had a stroke, or think you may have risk factors for these conditions (for example, high blood pressure, diabetes, high cholesterol, or smoking), please talk to your doctor or pharmacist.

Special Warnings

If you are a woman, SPEDIFEN 200 mg, Tablet may affect your fertility. It is not recommended for use in women who wish to conceive a child. In women who have difficulty conceiving or are undergoing reproductive testing, please talk to your doctor or pharmacist before using SPEDIFEN 200 mg, Tablet.

Elderly patients have a higher risk of adverse reactions, especially gastrointestinal bleeding, ulcers and perforations. Renal, hepatic and cardiac function should be closely monitored. Dosage should be kept as low as possible for the shortest time necessary to relieve symptoms.

This medication contains sodium. This medicine contains 41 mg of sodium per tablet. To be taken into account in patients controlling their dietary intake of sodium.

BEFORE USING THIS MEDICATION, CONSULT YOUR DOCTOR IF YOU HAVE:

• a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. The administration of this medicine may cause an asthma attack, especially in some people who are allergic to acetylsalicylic acid (aspirin) or to a non-steroidal anti-inflammatory drug(see section "Never take SPEDIFEN 200 mg, tablet in the following cases"),
• coagulation disorders, taking an anticoagulant treatment. This medicine may cause serious gastrointestinal symptoms,
• a history of digestive problems (hiatal hernia, digestive haemorrhage, ulcer of the stomach or duodenum),
• heart, liver or kidney disease,
• chicken pox. This medication is not recommended due to exceptional severe skin infections,
• concomitant treatment with other drugs that increase the risk of peptic ulcer or bleeding, for example, oral corticosteroids, antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), drugs that prevent blood clots such as aspirin, or anticoagulants such as warfarin If you have any of these conditions, talk to your doctor before taking SPEDIFEN 200 mg tablets(see "Taking or using other medicines"),
• concomitant treatment with methotrexate at doses higher than 20 mg per week or with pemetrexed(see "Taking or using other medicines").

DURING TREATMENT, IN CASE OF:

• visual disturbances, Warn your doctor,
• gastrointestinal haemorrhage (discharge of blood from the mouth or stools, black stools), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
• signs on the skin or mucous membranes that resemble a burn (redness with bullae or blisters, ulcerations), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
• signs of allergy to this medicine, including asthma attack or sudden swelling of the face and neck(see "What are the possible side effects?"), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY.

Taking or using other medications:

PLEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINE, EVEN IF IT IS A MEDICINE OBTAINED WITHOUT A PRESCRIPTION.

SOME MEDICATIONS CANNOT BE USED AT THE SAME TIME, WHILE OTHER MEDICATIONS REQUIRE SPECIFIC CHANGES (E.G., DOSE).

Always tell your doctor, dentist or pharmacist if you are taking any of the following medicines in addition to SPEDIFEN 200 mg, tablet:

• aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs
• corticosteroids
• oral anticoagulants such as warfarin, injectable heparin, antiplatelet agents or other thrombolytics such as ticlopidine
• lithium
• methotrexate
• angiotensin-converting enzyme inhibitors, diuretics, beta-blockers and angiotensin II antagonists
• certain antidepressants (selective serotonin reuptake inhibitors)
• pemetrexed
• ciclosporin, tacrolimus.

Not applicable.

Not applicable.

ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING ANY MEDICATION.

Pregnancy

During the first trimester of pregnancy (12 weeks of amenorrhea, i.e. 12 weeks after the^first day of your last menstrual period), your doctor may prescribe this medicine if necessary.

From 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medicine should only be used on the advice of your doctor and taken for short periods. Prolonged use of this medication is strongly discouraged.

If you are more than 5 months pregnant (more than 24 weeks of amenorrhea), you should NOT take this medicine under any circumstances, as its effects on your child may have serious consequences, particularly in terms of cardiopulmonary and renal health, even if you take it only once.

If you have taken this medicine when you are more than five months pregnant, please talk to your obstetrician-gynecologist so that appropriate monitoring can be offered to you.

Breastfeeding

This medicine passes into breast milk. As a precautionary measure, it should not be used during breastfeeding.

Not applicable.

Driving and use of machinery

In rare cases, dizziness and blurred vision may occur when taking this medicinal product.

Important information about some of the ingredients of SPEDIFEN 200 mg, tablet:

This medicine contains sodium.

3. HOW TO TAKE SPEDIFEN 200 mg, tablet

The occurrence of adverse reactions can be minimised by using the lowest possible dose for the shortest time necessary to relieve symptoms.

Dosage

Suitable for adults and children from 20 kg (approximately 6 years).

Painful and/or febrile conditions

In children, the usual dosage is 20 to 30 mg/kg/day in 3 doses per day (without exceeding 30 mg/kg/day).

In children from 20 to 30 kg (about 6 to 11 years): 1 tablet (200 mg), to be repeated if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (600 mg).

In adults and children weighing more than 30 kg (about 11-12 years): 1 to 2 tablets (200 mg to 400 mg), repeated if necessary after 6 hours. In all cases, do not exceed 6 tablets per day (1200 mg).

As the elderly are at increased risk of adverse effects, use the lowest possible dose for the shortest time necessary to relieve symptoms.

Do not exceed the recommended doses or duration of treatment (3 days for fever, 5 days for pain).

The maximum dosage is 6 tablets per day (1200 mg).

Mode and route of administration

Oral use.

Swallow the tablet, without chewing, with a large glass of water.

The tablets should preferably be taken with a meal.

Frequency of administration

Systematic administration avoids fluctuations in pain or fever.

They should be taken at least 6 hours apart.

Duration of treatment

If the pain persists for more than 5 days or the fever for more than 3 days, or if they worsen, or if another disorder occurs, inform your doctor.

If you feel that the effect of SPEDIFEN 200 mg, tablet is too strong or too weak: consult your doctor or pharmacist.

If you have taken more SPEDIFEN 200 mg, Tablet than you should have

In case of accidental overdose or intoxication, STOP THE TREATMENT AND SEEK MEDICAL ADVICE QUICKLY.

If you forget to take SPEDIFEN 200 mg, tablet: do not take a double dose to make up for the single dose you forgot to take.

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, SPEDIFEN 200 mg, Tablet may have side effects, although not everyone is likely to have them.

Medicines such as SPEDIFEN 200 mg, tablet may increase the risk of heart attack (myocardial infarction) or stroke.

Allergic reactions may occur:

• skin: rash on the skin, itching, swelling, aggravation of chronic urticaria,
• respiratory: asthma attack type,
• generalised: sudden swelling of the face and neck with breathing difficulties (angioedema).

In rare cases, gastrointestinal bleeding may occur(see "Special precautions with SPEDIFEN 200 mg, tablet"). The higher the dosage used, the more frequent it is.

In exceptional cases, headache with nausea, vomiting and neck stiffness may occur.

Very exceptionally, bullous manifestations of the skin or mucous membranes may occur (burning sensation accompanied by redness with bullae, blisters, ulcerations).

In exceptional cases, serious skin infections have been observed with chickenpox.

In all these cases, treatment should be stopped immediately and your doctor should be informed.

During treatment, the following may occur

• digestive disorders: stomach ache, vomiting, nausea, diarrhoea, constipation,
• exceptionally, dizziness, headaches, rare visual disturbances, significant decrease in urine output, kidney failure.

In all these cases, you must inform your doctor.

Rarely, changes in liver function or blood counts (decrease in white blood cells or red blood cells) that may be serious have been observed.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO USE SPEDIFEN 200 mg, tablet

Keep out of the reach and sight of children.

Do not use SPEDIFEN 200 mg, tablet after the expiry date stated on the box.

There are no special storage precautions.

Do not dispose of medicines in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

What does SPEDIFEN 200 mg tablet contain?

The active substance is:

Ibuprofen ................................................................................................................................... 200.00 mg

For one tablet.

The other components are:

Arginine, sodium bicarbonate, crospovidone, magnesium stearate, purified water.

What is SPEDIFEN 200 mg, tablet and what does it contain?

This medicine is presented in tablet form.

Box of 12, 16, 20 and 30 tablets.

Holder

ZAMBON FRANCE

13, RUE RENE JACQUES

92138 ISSY-LES-MOULINEAUX CEDEX

Operator

ZAMBON FRANCE

13, RUE RENE JACQUES

92138 ISSY-LES-MOULINEAUX CEDEX

Manufacturer

ZAMBON SPA

VIA DELLA CHIMICA, 9

36100 VICENZA

ITALY

Not applicable.

The last date of approval of this package insert was {date}.

Not applicable.

Detailed information on this medicinal product is available on the website of Afssaps (France).

Not applicable.

ADVICE / HEALTH EDUCATION

"WHAT TO DO IN CASE OF FEVER":

Normal body temperature varies from one individual to another and is between 36.5°C and 37.5°C. A rise of more than 0.8°C is considered a fever.

In adults and children over 20 kg (about 6 years old): If the symptoms are too severe, you can take a medicine containing ibuprofen in the indicated dosage.

With this medicine, the fever should drop quickly. Nevertheless:

• if other signs appear (such as a rash),
• if the fever lasts more than 3 days or gets worse,
• if the headache becomes severe, or in case of vomiting,

CONSULT YOUR DOCTOR IMMEDIATELY.

"WHAT TO DO IN CASE OF PAIN":

• If there is no improvement after 5 days of treatment,
• If the pain returns regularly,
• If it is accompanied by fever,
• If it wakes you up at night,

CONSULT YOUR DOCTOR IMMEDIATELY.