4. POSSIBLE SIDE EFFECTS
As with all medicines, some people may experience side effects with Megapen
If you experience any of the following events STOP taking your medicine and tell your doctor or go to your nearest hospital immediately:
- Hypersensitivity or severe allergic reaction including swollen face or breathing problems. If these symptoms occur, STOP taking Megapen right away and tell your doctor.
- Severe diarrhoea with bleeding
- Allergic skin reactions with itching e.g. hives, nettle rash, blistering or peeling of the skin. If you start to itch or get a rash, STOP taking Megapen and tell your doctor immediately.
- Convulsions may occur in patients on high doses or with kidney problems
- Notice your urine becoming darker or your faeces becoming paler
- Notice your skin or the white of your eyes turning yellow (jaundice)
- Difficulty or discomfort in passing urine or having cloudy urine
The following symptoms are less serious but you may wish to discuss them with your doctor if they become troublesome or last a long time.
Common side effects of Megapen (i.e. have been reported in more than 1 in 100 people taking it) include:
- Nausea (feeling sick) or diarrhoea
Uncommon side effects (i.e. have been reported in between 1 in 100 and 1 in 1,000 people taking Megapen) include:
Very rare side effects (i.e. reported in less than 1 in 10,000 people) include:
- Thrush (a yeast infection of the vagina, mouth or skin folds). You can get treatment for thrush from your doctor or pharmacist.
- Tooth discolouration. The colour usually returns to normal with brushing.
- Blackening of the tongue
- Inflammation of the kidney
- Excessive body movements (hyperkinesia) or dizziness
- Reduction (reversible) in blood cell counts including anaemia (a reduction in the body s red blood cells or haemoglobin which may be characterised by feeling weak or light-headed) or a longer time taken for blood to clot. Tell your doctor that you are taking Megapen if you are having blood tests.
- Crystalluria, forming of crystals in the urine
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
How to take it
Swallow Megapen capsules whole with a drink of water. Do not chew or break them.
Megapen is available as a liquid for children and people who find it difficult to swallow tablets.
If you or your child are taking Megapen as a liquid, it will usually be made up for you by your pharmacist. The medicine will come with a plastic syringe or spoon to help you measure out the right dose.
If you don't have one, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not give the right amount.
6. FURTHER INFORMATION
The name of your medicine is Megapen Capsules. Megapen Capsules are available only on prescription from your doctor.
What Megapen capsules contain
Each capsule contains either 250 mg or 500 mg of Megapen as Megapen trihydrate. The capsules also contain the following inactive ingredients: magnesium stearate, maize starch, gelatin, erythrosin (E127), quinoline yellow (E104), titanium dioxide (E171), red iron oxide (E172).
What Megapen capsules look like and contents of the pack
Megapen Capsules are scarlet and ivory opaque hard gelatin capsules, each capsule is marked with the characters “AMOX 250” or “AMOX 500”.
Securitainers are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 500 & 1000 capsules, the pack size of 1000 is available for the 250mg strength only.
Blister packs are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 500 & 1000 capsules, the pack size of 1000 is available for the 250mg strength only.
The product is made by Athlone Laboratories Limited, Ballymurray, Co.Roscommon, Ireland. The product licence is also held by Athlone Laboratories Limited.
The Product is distributed by Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
PL 06453/0017 PL 06453/0018
Date of revision October 2011
Q: Celestamine, Piriton, Amoxil, and Flugone are the drugs that I occasionally take. What are the side effects?
A: Amoxil (Megapen) is an antibiotic that is used to treat a wide variety of bacterial infections. The most common side effects of Megapen are diarrhea, nausea, and vomiting. Rarely, severe side effects can occur when taking Megapen such as severe allergic reactions (rash, hives, itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; stomach pain or cramps; and unusual bruising or bleeding. Stop taking Megapen immediately, and consult your physician immediately if any of these severe effects occur. Celestamine, Piriton, and Flugone are not approved for use in the United States; therefore, I cannot provide any information about these medications. Burton Dunaway, PharmD
Q: I got hives from taking Megapen. I still have them three weeks later, after I am off the medication.
A: Amoxil (Megapen) is an antibiotic used to stop bacterial infections, and side effects do not include hives. You may be having an allergic reaction and should contact your doctor. Many people are allergic to the medication, and if your doctor confirms an allergy, you should also let your pharmacy know, so they can put the information in their computers. That way, if any doctor prescribed a type of penicillin, the pharmacy will be alerted to the allergy. Common side effects from Amoxil (Megapen) may include upset stomach, diarrhea, and vomiting. This is not a complete list of the side effects associated with Amoxil (Megapen). Patti Brown, PharmD
Megapen is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.