500 mg/125 mg film-coated tablets
amoxicillin/clavulanic acid
What Spektramox is and what it is used for
Spectramox is an antibiotic that works by killing bacteria that cause infection. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called ‘penicillins’ which can sometimes stop working (become inactive). The other active substance ( clavulanic acid ) prevents this from happening.
Spectramox is used in adults and children to treat the following infections:
- infection in the middle ear and sinus infections
- respiratory tract infections
- urinary tract infections
- skin and soft tissue infections including dental infections
- bone and joint infections.
What you need to know before taking Spektramox
Do not take Spektramox:
- if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
- if you have had a severe allergic reaction ( hypersensitivity reaction ) to any other antibiotic. This may include a rash or swelling of the face or neck.
- if you have had liver problems or jaundice (yellowish skin) when you have taken an antibiotic.
- Do not take Spektramox if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Spektramox.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
- have glandular fever
- being treated for liver or kidney problems
- not peeing regularly.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Spektramox.
In some cases, your doctor can investigate the type of bacteria causing your infection. Depending on the results, you may receive a different strength of Spektramox or another medicine.
Conditions you must be aware of:
Spectramox can worsen certain existing conditions, or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the colon. You need to be aware of certain symptoms when taking Spektramox to reduce the risk of possible problems. See “Conditions you need to be aware of” in section 4.
Blood and urine samples
If you are having blood tests (eg to check red blood cells or liver function tests) or urine tests (for glucose ), tell the doctor or nurse that you are taking Spektramox. This is because Spektramox can affect the results of these types of samples.
Other medicines and Spektramox
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you take allopurinol (for gout ) together with Spektramox, the risk of an allergic skin reaction may be greater.
If you take probenecid (for gout ), the doctor can change the dose of Spektramox.
If you are taking blood-thinning medicines to prevent blood clots (eg warfarin ) together with Spektramox, you may need to provide extra blood samples.
Spectramox can affect how methotrexate (a medicine to treat cancer or rheumatic diseases) works.
Spectramox can affect how mycophenolate mofetil (a medicine that prevents the rejection of transplanted organs) works.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving ability and use of machinery
Spektramox can have side effects and the symptoms can make you unfit to drive. Do not drive or use machines if you feel unwell.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Spectramox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Spektramox
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Adults and children weighing 40 kg or more
The usual dose is:
- 1 tablet 3 times daily
Children weighing less than 40 kg
Children who are 6 years of age or younger should preferably be treated with Spektramox oral suspension.
Consult a doctor or pharmacist when giving Spektramox tablets to children weighing less than 40 kg.
Patients with kidney and liver problems
- The dose may be changed if you have kidney problems. Your doctor may choose a different strength or different medicine.
- If you have liver problems, you may be given more frequent blood tests to check how your liver is working.
How to take Spektramox
- Swallow the tablets whole with a glass of water at the beginning of a meal or just before.
- Distribute the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
- Do not take Spektramox for more than 2 weeks. If you still feel unwell, see a doctor again.
If you have taken too much Spektramox
If you have taken too much Spektramox, you may have symptoms such as an upset stomach (nausea, vomiting, or diarrhea) or convulsions. Contact the doctor as soon as possible. Take the box or bottle of medicine with you and show the doctor.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, or hospital for an assessment of the risk and advice.
If you forget to take Spektramox
If you have forgotten a dose, take it as soon as you remember. You should not take the next dose too soon, but wait about 4 hours before taking it.
If you stop taking Spektramox
Continue to take Spektramox until the treatment is finished, even if you feel better. You need every dose to fight infection. If some bacteria survive, it can lead to a recurrence of the infection.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you must be aware of:
Allergic reactions:
Has occurred in a very small number of people:
- rash
- inflammation of blood vessels ( vasculitis ) which can be seen as red or purple, raised spots on the skin but can affect other parts of the body
- fever, joint pain, swollen glands on the neck, in the armpits, or the groin
- swelling, sometimes of the face or mouth ( angioedema ) leading to breathing difficulties
- collapse.
- Contact a doctor immediately if you experience any of these symptoms. Stop taking Spectramox.
Inflammation of the colon
Has occurred in a very small number of people:
- Inflammation of the colon causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.
- Contact your doctor as soon as possible for advice if you experience these symptoms.
Serious skin reactions
It May affect up to 1 in 1,000 people:
- skin rash, which may blister and look like small targets (a dark dot in the center surrounded by a paler area, with a dark ring around the edge – erythema multiforme )
Has occurred in a very small number of people:
- a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), and a more severe form that causes extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis )
- an extensive red rash with small blisters where ( bullous exfoliative dermatitis )
- a red, scaly rash with bumps under the skin and blisters ( exanthematous pustulosis ).
- flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count ( eosinophilia ) and liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
- Contact a doctor immediately if you experience any of these symptoms.
Very common side effects are
These may affect more than 1 in 10 people
- with diarrhea (in adults).
Common side effects are
These may affect up to 1 in 10 people
- thrush ( candida – a yeast infection in the vagina, mouth, or skin folds)
- nausea, especially when taking high doses
- if you suffer from this, take Spektramox before a meal
- vomiting
- diarrhea (in children).
Less common side effects are
These may affect up to 1 in 100 people
- skin rash, itching
- raised, itchy rash (hives)
- indigestion
- dizziness
- headache.
Less common side effects that may show up in blood tests:
- increase in certain substances ( enzymes ) produced in the liver.
Rare side effects ar
These may affect up to 1 in 1,000 people
Rare side effects that can show up in blood tests:
- the low number of blood cells that are involved in the coagulation of the blood
- low white blood cell count.
Other side effects that have been reported
These side effects have occurred in a very small number of people, but their exact incidence is unknown.
- inflammation of the liver ( hepatitis )
- inflammation of the meninges and spinal cord ( aseptic meningitis )
- jaundice is caused by increases in bilirubin in the blood (a substance produced in the liver) which can make the skin and whites of the eyes look yellow
- inflammation of the kidneys
- it takes longer for the blood to clot
- hyperactivity
- seizures (in people taking high doses of Spektramox or who have kidney problems)
- a black tongue that looks hairy
- stains on the teeth (in children), usually go away with brushing.
Side effects that can show up in blood or urine tests:
- Severe decrease in the number of white blood cells
- low red blood cell count ( hemolytic anemia )
- crystals in the urine.
How to store Spektramox
Keep this medicine out of the sight and reach of children.
Tablets in a jar: Store in the original packaging.
Tablets in blisters: Store at a maximum of 25ºC.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment
Contents of the packaging and other information
Contents declaration
The active substances are: amoxicillin and clavulanic acid
1 tablet contains amoxicillin trihydrate corresponding to amoxicillin 500 mg and potassium clavulanate corresponding to clavulanic acid 125 mg.
Other ingredients are sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, and microcrystalline cellulose. Film coating: dye (titanium dioxide E 171), hypromellose, macrogol, dimethicone.
Appearance and package sizes of the medicine
White, oval, film-coated tablets, marked with score and AC on one side.
Package size:
20, 30, and 100 pcs.
Marketing Authorisation Holder
Viatris AB
Box 23033
104 35 Stockholm
Telephone 08-630 19 00