Ibuprofen And Phenylephrine Hydrochloride 200 Mg/5 Mg Film-Coated Tablets
Out of date information, search anotherSafety update: Paediatric Regulation - Public Assessment Report according to Article 45
Package leaflet: information for the patient
Ibuprofen and phenylephrine hydrochloride 200mg/5mg film-coated tablets
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use 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 3 days in adolescents and after 3-5 days in adults.
What is in this leaflet:
1. What Ibuprofen/Phenylephrine is and what it is used for
2. What you need to know before you take Ibuprofen/Phenylephrine
3. How to take Ibuprofen/Phenylephrine
4. Possible side effects
5. How to store Ibuprofen/Phenylephrine
6. Contents of the pack and other information
1. What Ibuprofen/Phenylephrine is and what it is used for
The name of your medicine is Ibuprofen and phenylephrine hydrochloride 200mg/5mg film-coated tablets (called Ibuprofen/Phenylephrine throughout this leaflet). Ibuprofen and phenylephrine hydrochloride 200mg/5mg film-coated tablets contains ibuprofen and phenylephrine hydrochloride, which are effective in relieving the symptoms of influenza and cold, including fever, headache, painful sinuses, sore throat and muscle and joint pain. Moreover, it helps with runny nose, relieves stuffy nose and nasal sinuses, facilitating breathing.
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) and is effective against aches and pains (including headache), swelling and can also reduce a fever. Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache.
Use Ibuprofen/Phenylephrine only if you have colds or influenza accompanied by stuffy nose. If you do not have stuffy nose, monocomponent products containing only ibuprofen should be preferred.
The product is intended for adults and adolescents aged 12 years and over.
2. What you need to know before you take Ibuprofen/Phenylephrine
Do not take Ibuprofen/Phenylephrine if you
- are allergic to ibuprofen, phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6) and at hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs manifested as shortness of breath, asthma or urticaria,
- have active or recurrent ulcer or bleeding to the stomach or duodenum or if you have ever had it repeatedly (i.e. at least twice) in the past,
- have ever had gastrointestinal bleeding or perforation, related to previous NSAIDs therapy,
- suffer from disorder of blood formation or disorder of blood clotting,
- have severe high blood pressure or severe heart, liver or kidney failure,
- are a woman in the third trimester of pregnancy,
- have diabetes,
- have an overactive thyroid gland (hyperthyroidism),
- have narrow-angle glaucoma,
- have urinary retention (lack of ability to urinate),
- have a vascular tumour near your kidney (pheochromocytoma),
- are currently taking:
- medicines used to treat depression (from the group of monoamine oxidase inhibitors, MAOIs) or you have taken them within the last two weeks,
- medicines used to treat depression (from the group of tricyclic antidepressants),
- medicines used to treat high blood pressure or heart disease (from the group of beta-blockers),
- sympathomimetics (medicine for the relief of congestion of the mucous membranes) including the medicines administered by several routes, i.e. orally and topically (nasal, aural and eye medicines).
If you are not sure whether any of the conditions mentioned above applies to you, ask your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Ibuprofen/Phenylephrine if you:
- have or have ever had bowel problems,
- suffer from inflammatory ulcerous disease of digestive tract such as Crohn's disease or ulcerative colitis,
- suffer from kidney or liver disorder,
- suffer from bronchial asthma, hay fever, nasal polyps or chronic obstructive respiratory disorders,
- directly after major surgery,
- suffer from systemic lupus erythematodes (immunity system disorder) and other disorders of the connective tissue (the risk of aseptic meningitis),
- have heart problems, a history of stroke or think that you might be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker),
- are a man with prostate enlargement (prostate hypertrophy).
Medicines such as Ibuprofen/Phenylephrine may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Some concomitant medications could increase the risk of gastrotoxicity or bleeding (other non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or anti-platelet agents such as acetylsalicylic acid).
In patients with increased risk of gastrointestinal toxicity concomitant use of protective agents should be considered.
If you previously had gastrointestinal toxicity, particularly when elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment to your doctor.
Children and adolescents
The product is not intended for children under 12 years.
There is a risk of renal impairment in dehydrated children and adolescents.
Other medicines and Ibuprofen/Phenylephrine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use Ibuprofen/Phenylephrine, if you are taking:
- any other medicines containing acetylsalicylic acid or other NSAIDs,
- medicines for cold and flu,
- medicines for treating nasal congestion (stuffy nose),
- or have taken antidepressants within the last two weeks (see section “Do not take Ibuprofen/Phenylephrine” above),
- sympathomimetic drugs (see section “Do not take Ibuprofen/Phenylephrine” above),
- medicines used to treat high blood pressure or heart diseases (from the group of beta-blockers) (see section “Do not take Ibuprofen/Phenylephrine” above).
Consult your doctor or pharmacist before you start using Ibuprofen/Phenylephrine, if you are taking:
- corticosteroids,
- medicines for high blood pressure and water tablets,
- medicines for thinning the blood (such as warfarin) and anti-platelet agents,
- selective serotonin reuptake inhibitors (SSRIs) (medicines used for depression),
- some of antibiotics (quinolone, aminoglycosides),
- sulphonylurea derivatives (antidiabetic drugs),
- products containing lithium (a medicine for manic depressive illness and depression), methotrexate (a medicine for cancer or rheumatism), sulfinpyrazone and probenecid (medicines for gout), cyclosporin and tacrolimus (immunosuppressive medicines), zidovudine (a medicine for treating AIDS), digoxin (for heart insufficiency), phenytoin (for epilepsy), baclofen (used for treating spasm of skeletal muscles), ergotamine and methysergide (drugs used in the treatment of migraine attack), mifepristone (the abortion pill).
Ibuprofen/Phenylephrine with food, drink and alcohol
The tablet may be taken with or without food. If taken with food or shortly after eating, the onset of action may be delayed. However taking it with food improves tolerability of the medicine and reduces probability of gastrointestinal problems. Drinking of alcoholic beverages and smoking is not suitable during treatment.
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. Ibuprofen/Phenylephrine is not recommended for pregnant and breast-feeding women.
The product belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.
Driving and using machines
Ibuprofen/Phenylephrine has no influence on the ability to drive or operate machinery. However, for some people, this medicine may cause dizziness, thereby it may adversely affect activities requiring increased attention. Do not drive or use machines if this happens to you.
3. How to use Ibuprofen/Phenylephrine
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.
Adults and adolescents aged 12 years and over:
This medicine is intended for short-term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Usual dose is 2 tablets every 8 hours. Leave at least 4 hours between doses and do not take more than 6 tablets per 24 hours.
Do not take this medicine for more than 3-5 days without consulting your physician.
If you are an adult and your signs of illness do not resolve, or if they worsen or persist longer than 3-5 days, you should consult your doctor. If in adolescents (12 years of age and above) this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Do not exceed the recommended dose or duration of treatment.
Tablets should be swallowed as a whole and followed with a sufficient amount of liquid. It is important to drink plenty of fluids when suffering from colds and flu.
Elderly
In elderly patients the dosage is the same like in adults, but increased caution is necessary (see section “Warnings and precautions” above)
Patients with impaired liver or kidney function
In patients with liver and kidney insufficiency increased caution is necessary (see section “Warnings and precautions” above).
If you take more Ibuprofen/Phenylephrine than you should
If you take more of this medicine than you should or if a child accidentally ingests this medicine, you should seek immediate medical advice, even if you feel well.
If you forget to take Ibuprofen/Phenylephrine
If you forget to take a dose, take the next dose as soon as you remember, provided that you took the last dose at least 4 hours ago. Do not take a double dose to make up for a forgotten tablet dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
There is an increased probability of side effects occurring in the elderly, people with a history of stomach or duodenal ulcers (mainly with bleeding or mucosa perforation) or in people receiving long-term treatment with products containing acetylsalicylic acid.
Stop taking this medicine and seek immediate medical attention if you experience the following:
• Serious allergic reactions (including potentially fatal anaphylactic shock) which can cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing. Very rare frequency of occurrence.
• Serious skin reaction with purplish spots or patches on the skin, blisters, peeling of the skin, (high) fever, joint pain and/or eye inflammation (Stevens Johnson syndrome/toxic epidermal necrolysis). Very rare frequency of occurrence.
• Severe reduction in number of white blood cells which makes infections more likely, high fever, lesions of the mucous membranes and skin. Very rare frequency of occurrence.
• Digestive problems such as pain in stomach or other abnormal stomach symptoms (common frequency of occurrence); pass bloody or black stools, vomit any blood or dark particles that look like coffee grounds (rare frequency of occurrence).
The other side effects which may occur are listed below grouped according to the frequency:
Very common (may affect more than 1 in 10 people):
- Indigestion, feeling sick (nausea), being sick (vomiting), diarrhoea, wind, constipation.
Common (may affect up to 1 in 10 people):
- Headache, dizziness, inability to fall asleep (insomnia).
Uncommon (may affect up to 1 in 100 people):
- Urticaria, itching, rash.
- Ringing in the ears.
Rare (may affect up to 1 in 1,000 people):
- Inflammation of the protective membranes covering the brain and spinal cord (meningitis).
- Vision disorders, colour blindness.
- Ulceration or rupture in the stomach, gullet or intestines, dark or black stools and vomiting of blood.
- Nervousness.
Very rare (may affect up to 1 in 10,000 people):
- Depression.
- Feeling your heartbeat, heart failure, increased blood pressure.
- Blood disorders (first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, unexplained bleeding and bruising).
- Mouth ulcers, stomach inflammation, worsening of existing bowel disease (colitis or Crohn’s disease).
- Liver or kidney problems (possible kidney failure, inflammation of the kidneys), blood in the urine, bladder inflammation.
Not known (frequency cannot be estimated from the available data):
- Irregular or faster heartbeat.
- Eye pain and stinging, blurred vision, sensitivity to or intolerance of light, acute angle closure glaucoma (eye pain).
- Difficulty in breathing or wheezing (predominantly in patients with bronchial asthma), aggravation of asthma.
Medicines such as Ibuprofen/Phenylephrine may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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 the Yellow card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ibuprofen/Phenylephrine
Keep this medicine out of the sight and reach of children.
Store below 25°C. Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the package after EXP.
The expiry date refers to the last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What Ibuprofen and phenylephrine hydrochloride 200mg/5mg film-coated tablets contain
The active substances are ibuprofen 200 mg and phenylephrine hydrochloride 5 mg in each tablet.
The other ingredients are maize starch, maize starch pregelatinised, sodium starch glycolate (type A), talc, povidone 30, silica, colloidal anhydrous, stearic acid 50, hypromellose 2910/5, macrogol 6000, titanium dioxide (E171).
What Ibuprofen and phenylephrine hydrochloride 200mg/5mg film-coated tablets look like and contents of the pack
Ibuprofen and phenylephrine hydrochloride 200mg/5mg film-coated tablets are white to off-white biconvex film-coated tablets with diameter of approx. 10.6 mm.
Pack size: 12 and 24 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS
Manufacturer:
Zentiva, k.s., Dolni Mecholupy, 102 37 Prague 10, Czech Republic.