Patient leaflet - Care Cold & Flu Relief 200 mg/5 mg film coated tablets
1. What Care Cold & Flu Relief 200mg/5mg Film Coated Tablets is and what it is used for
Care Cold & Flu Relief 200mg/5mg Film Coated Tablets contains ibuprofen and phenylephrine hydrochloride, which are effective in relieving the symptoms associated with colds and flu, including relief of aches and pains, sore throats, headache, nasal congestion (blocked nose) and lowering of temperature.
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.
2. What you need to know before you take Care Cold & Flu Relief 200mg/5mg Film Coated Tablets
DO NOT take this medicine if you:
- are allergic to ibuprofen, phenylephrine hydrochloride or any of the other ingredients of this medicine (see section 6), or to aspirin or other painkillers.
- have ever had a stomach ulcer, perforation or bleeding.
- have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines.
- have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
- are taking other NSAID painkillers.
- are taking more than 75mg of aspirin a day. If you are on a low-dose aspirin (up to 75mg daily) talk to your doctor or pharmacist before you take Care Cold & Flu Relief 200mg/5mg Film Coated Tablets.
- have severe liver or kidney problems.
- have severe heart problems (severe heart failure), high blood pressure or blood coagulation disorder.
- have breathing difficulties.
- have prostate problems.
- have an overactive thyroid.
- are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (usually used to treat depression).
- are in the last 3 months of pregnancy.
- are under 12 years old.
Warnings and precautions
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop using Care Cold & Flu Relief 200mg/5mg Film Coated Tablets immediately and contact your doctor or medical emergencies if you notice any of these signs.
Talk to your doctor or pharmacist before taking Care Cold & Flu Relief 200mg/5mg Film Coated Tablets if you:
- have or have had asthma.
- have kidney, heart, liver or bowel problems.
- have high cholesterol or previously have had a heart attack or stroke.
- have a history of gastrointestinal disease (such as ulcerative colitis or Crohn’s disease).
- have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain, skin changes or other organ disorders).
- are a smoker.
- are in the first 6 months of pregnancy.
- 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 (myocardial infarction) or stroke, particularly when used at high doses and/or prolonged treatment.
Do not exceed the recommended dose or duration of treatment (10 days). If you are taking Care Cold & Flu Relief 200mg/5mg Tablets for longer than the recommended time or at higher than recommended doses you are at risk of serious harm. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).
Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. You should stop taking Care Cold & Flu Relief 200mg/5mg Film Coated Tablets 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.
You should discuss your treatment with your doctor or pharmacist before taking Care Cold & Flu Relief 200mg/5mg Film Coated Tablets 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 ‘mini-stroke’ or transient ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Infections:
Care Cold & Flu Relief 200mg/5mg Film Coated Tablets may hide signs of infections such as fever and pain. It is therefore possible that this medicine 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.
Other medicines and Care Cold & Flu Relief 200mg/5mg Film Coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
To reduce the risk of side effects, do not take this medicine with other NSAID containing products (e.g. aspirin, ibuprofen).
If you are on low-dose aspirin (up to 75mg daily) talk to your doctor or pharmacist before you take this medicine.
Care Cold & Flu Relief 200mg/5mg Film Coated Tablets may affect or be affected by some other medicines. For example, avoid taking this medicine with medicines:
- used for the treatment of asthma and various inflammatory conditions (corticosteroid tablets, e.g. prednisolone, beclomethasone).
- to treat certain bacterial infections (quinolone antibiotics, e.g. ciprofloxacin, norfloxacin, levofloxacin).
- that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine).
- to stimulate your heart (e.g. glycosides) or medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan).
- to help you pass water (diuretics).
- for the temporary suppression of your immune system (e.g. methotrexate, ciclosporin, tacrolimus).
- for mania or depression (e.g. lithium or SSRIs).
- for pregnancy termination (e.g. mifepristone).
- for HIV treatment (e.g. zidovudine).
- containing other sympathomimetic agents such as decongestants (e.g. pseudoephedrine). Some other medicines may also affect or be affected by treatment of Care Cold & Flu Relief 200mg/5mg Film Coated Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Care Cold & Flu Relief 200mg/5mg Film Coated Tablets with other medicines.
Pregnancy, breast-feeding and fertility
Care Cold & Flu Relief 200mg/5mg Film Coated Tablets belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking this medicine. It is unlikely that if you only take Care Cold & Flu Relief 200mg/5mg Film Coated Tablets occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.
Tell your doctor if you become pregnant whilst taking Care Cold & Flu Relief 200mg/5mg Film Coated Tablets
Do not take Care Cold & Flu Relief 200mg/5mg Film Coated Tablets if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect you and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take Care Cold & Flu Relief 200mg/5mg Film Coated Tablets during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Care Cold & Flu Relief 200mg/5mg Film Coated Tablets can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
Talk to your doctor or pharmacist before taking this medicine if you are breast-feeding. Sodium Content
This medicine contains less than 1 mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.
3. How to take Care Cold & Flu Relief 200mg/5mg Film Coated Tablets
Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 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). Method of administration
Tablets must be swallowed whole with water.
It is important to drink plenty of fluids when suffering from colds and flu. Dosage
Adults, the elderly and children over 12 years:
Take two tablets every 8 hours. Leave at least 4 hours between doses and do not exceed 6 tablets in any 24 hour period.
Duration of treatment
- This medicine is for short-term use only.
- Take the lowest dose for the shortest time necessary.
Do not take Care Cold & Flu Relief 200mg/5mg Film Coated Tablets for longer than 10 days.
If you do not get better, or get worse, talk to your doctor. They will tell you if it is safe to carry on taking this medicine.
Do not give to children under 12 years.
If you take more Care Cold & Flu Relief 200mg/5mg Film Coated Tablets than you should:
If you have taken more of this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital immediately to get an opinion of the risk and advice on action to be taken, even if you feel well. 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. If you forget to take Care Cold & Flu Relief 200mg/5mg Film Coated Tablets
Refer to the directions above on how to take this medicine and do not take more than is advised.
DO NOT take a double dose to make up for forgotten tablets.
4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them. Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. You may suffer one of the known side effects of NSAIDs (see below). If you get any of the following at any time during your treatment STOP TAKING, and tell your doctor or pharmacist straight away:
- signs of intestinal bleeding such as:
- pass blood in your stools or motions.
- pass black tarry stools or motions.
- vomit any blood or dark particles that look like coffee grounds.
- signs of serious allergic reaction such as:
- difficulties in breathing or unexplained wheezing.
- dizziness or faster heartbeat.
- severe forms of skin reactions such as itchiness.
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
- widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome). - a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).
- swelling of your face, tongue or throat.
- chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
- signs of kidney problems such as:
- passing less or more urine.
- cloudy urine or blood in urine.
- pain in the back and/or swelling (particularly in the legs).
- signs of aseptic meningitis such as:
- neck stiffness.
- headache.
- feeling sick, being sick.
- fever or disorientation. Patients with autoimmune disorders (Systemic Lupus Erythematosus, mixed connective-tissue disease) may be more likely to be affected.
- signs of blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion.
- signs of liver problems such as stomach pain, nausea, jaundice (yellowing of the skin and the whites of the eyes) or passing dark brown urine.
•Liver, kidney problems or difficulty urinating.
Care Cold & Flu Relief Tablets, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.
STOP TAKING this medicine and tell your doctor if you experience the following uncommon side effects which may affect up to 1 in 100 people:
- indigestion or heartburn.
- pains in your stomach (abdomen) or other abnormal stomach problems. TELL YOUR DOCTOR if you have any of the following side effects, they become worse or you notice any effects not listed:
Uncommon side effects which may affect up to 1 in 100 people:
- allergic reactions, such as skin rashes (urticaria), itching, peeling.
- headaches, dizziness, tinnitus (ringing in the ears).
Rare side effects which may affect up to 1 in 1,000 people:
- flatulence (wind), diarrhoea, constipation and vomiting.
Very rare side effects which may affect up to 1 in 10,000 people:
- blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion.
- drop in blood pressure or irregular heart beat.
- liver problems.
Side effects for which the frequency cannot be estimated from the available data:
- worsening of asthma or bronchospasm.
- swelling (oedema), high blood pressure, heart failure or attack.
- worsening of colitis and Crohn’s disease.
- difficulties in passing urine (in men only).
- 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).
- 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). Stop using Care Cold & Flu Relief 200mg/5mg Film Coated Tablets if you develop these symptoms and seek medical attention immediately. See also section 2.
- Skin becomes sensitive to light.
Medicines such as Care Cold & Flu Relief 200mg/5mg Film Coated Tablets may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. See section 2 “Warnings and precautions”.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 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 Care Cold & Flu Relief 200mg/5mg Film Coated Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP month/year) which is stated on the pack. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Care Cold & Flu Relief 200mg/5mg Film Coated Tablets contains
The active substances are:
- ibuprofen
- phenylephrine hydrochloride
Each film-coated tablet contains:
- 200mg ibuprofen
- 5mg phenylephrine hydrochloride
The other ingredients are:
The core consists of:
- microcrystalline cellulose
- sodium starch glycolate
- hypromellose
- sodium stearyl fumarate
- purified water
The film consists of:
- polyvinyl alcohol
- talc
- macrogol
- titanium dioxide
- methacrylic acid copolymer
- sodium bicarbonate
- purified water.
What Care Cold & Flu Relief 200mg/5mg Film Coated Tablets looks like and contents of the pack
Care Cold & Flu Relief 200mg/5mg Film Coated Tablets are white, round, biconvex, film-coated tablets with a score line on
one side. The score line is not intended for breaking the tablet.
The product is available in cartons of 12 and 16 tablets.
Marketing Authorisation Holder
Thornton & Ross Ltd
Linthwaite
Huddersfield
HD7 5QH
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Product Licence Number: PL 00240/0382