Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Potassium para-aminobenzoate 3 g Powder Sachets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Potassium para-aminobenzoate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR The active ingredient in Potassium para-aminobenzoate Powder is potassium paraaminobenzoate. It is used in the treatment of Peyronie's disease (the growth of fibrous plaques in the soft tissue of the penis) and scleroderma (excessive deposits of collagen in the skin or other organs). Potassium para-aminobenzoate is an antifibrosis agent, which acts by increasing oxygen uptake by the tissues.
What you need to know before you take it
E POTASSIUM PARAAMINOBENZOATE POWDER Do not take Potassium para-aminobenzoate Powder: • • • • • •
if you are allergic to potassium para-aminobenzoate or other substances with similar chemical structure (e.g. benzocaine, procaine, ethyl parahydroxybenzoate) or any of the other ingredients of this medicine (listed in section 6) if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Potassium para-aminobenzoate Powder if you have kidney disease if you have a raised level of potassium in your blood (each sachet contains 669 mg potassium) if you are taking sulfonamides or combinations of sulfonamides with other antibiotics (e.g. sulfamethoxazole, sulfadimidine or co-trimoxazole) if you have severe liver damage
Warnings and precautions
You may need to stop taking Potassium para-aminobenzoate Powder for a while if you are not eating enough food (e.g. if you are fasting, have anorexia or are feeling sick). This is to reduce the risk of your blood sugar levels falling too low (see section 4). Your condition will need to be carefully monitored by your doctor to ensure you do not become oversensitive to the medication, in which case treatment with Potassium paraaminobenzoate will be stopped. Symptoms of this include fever, rash and tiredness. Furthermore, your doctor will regularly monitor your liver function. In case of elevated liver function tests, treatment with Potassium para-aminobenzoate Powder will be stopped. Talk to your doctor or pharmacist before taking Potassium para-aminobenzoate Powder: Special caution is required,
- if you notice any of the symptoms related to these serious skin reactions described in section 4, stop using Potassium para-aminobenzoate Powder and seek medical attention immediately
- if you have kidney problems or any other condition that may cause high blood levels of potassium, Potassium para-aminobenzoate Powder should be used with caution
- if you experience symptoms possibly indicative of an increased potassium level in your blood while or after taking Potassium para-aminobenzoate Powder, please advise your doctor accordingly. Such symptoms include for example muscle pain or tightness, muscle weakness with reduced muscle tone, weakness, a tingling, pricking, chilling, burning or numb sensation of the skin, an awareness of an abnormal or slow heartbeat, or rapid breathing
- if you have a liver disorder or disease – your doctor will monitor your liver function
- if you experience symptoms possibly indicative of a liver disorder while or after taking Potassium para-aminobenzoate Powder, please advise your doctor immediately. Such symptoms include for example nausea, vomiting, loss of appetite, fever, a change of your urine colour or a yellowish or greenish staining of your skin and/or eyes Children and adolescents Potassium para-aminobenzoate Powder is not recommended for the use in children and adolescents. Other medicines and Potassium para-aminobenzoate Powder Please check with your doctor if you are taking any of the following medicines before taking Potassium para-aminobenzoate Powder: • • • • • • • • •
medicines known as sulfonamide antibiotics, e.g. co-trimoxazole or sulfadimidine methotrexate, a medicine used to treat cancer, arthritis and psoriasis digoxin, or any other cardiac glycoside, used to treat heart failure medicines known as aldosterone antagonists, e.g. eplenerone, spironolactone, used to treat high blood pressure and certain liver and kidney problems medicines known as potassium-sparing diuretics, e.g. amiloride, triamterene, used to treat high blood pressure and certain heart diseases medicines known as ACE-inhibitors, e.g. ramipril, lisinopril, enalapril, used to treat high blood pressure and certain heart and kidney problems medicines known as beta blockers, e.g. atenolol, bisoprolol, metoprolol, propranolol, used to treat high blood pressure and certain heart problems medicines known as non-steroidal anti-inflammatory drugs, e.g. ibuprofen, naproxen, diclofenac, used to treat pain, certain inflammatory conditions and fever medicines known as angiotensin receptor blockers or sartans, e.g. candesartan, irbesartan, losartan, valsartan, used to treat high blood pressure and heart failure
- medicines known as calcineurin inhibitors, e.g. ciclosporin or tacrolimus, used to treat certain autoimmune diseases like rheumatoid arthritis, psoriasis or atopic dermatitis, and to prevent transplant rejection after organ transplantation
- medicines known as penicillin antibiotics, e.g. phenoxymethylpenicillin, amoxicillin or flucloxacillin
- pentamidine, a medicine used to treat certain parasite infections
- ketoconazole, a medicine used treat certain fungal infections
- medicines known as heparin and heparin derivatives, e.g. enoxaparin, dalteparin, tinzaparin, used to prevent formation of blood clots (thrombosis)
- potassium supplements and other medicinal products containing high potassium amounts Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. Potassium para-aminobenzoate Powder with food and drink Always take Potassium para-aminobenzoate Powder with food, dissolving the powder in cold water or fruit juice. If you do not, there is a risk that you may feel slightly sick. If, for any reason, you are not eating, or are just eating very small amounts, it is advisable that you stop taking Potassium para-aminobenzoate Powder until you start eating normally again. It is possible that if you do not interrupt treatment the levels of sugar in your blood may become too low and you may feel unwell. In the elderly, the low blood sugar that may occur during periods of low food intake may be more difficult to recognise and may cause more neurological symptoms. Pregnancy and breast feeding 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. Driving and using machines Potassium para-aminobenzoate Powder should not affect your ability to drive or operate machinery. However, if you feel confused, sleepy or weak whilst taking your medicine do not drive or operate machinery until these symptoms have gone.
How to take it
POTASSIUM PARA-AMINOBENZOATE POWDER 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 powder should be dissolved in cold water or fruit juice, to make it more pleasant to take, and drunk during mealtimes. The recommended dose is 12 g a day. This is the equivalent of 4 sachets a day. The dosage should be spread throughout the day as evenly as possible, to maintain the level of medicine in your system, making sure you swallow the medicine with food. Potassium para-aminobenzoate Powder should be taken for as long as your doctor has recommended. Use in children and adolescents Potassium para-aminobenzoate Powder is not recommended for use in children and adolescents.
If you take more Potassium para-aminobenzoate Powder than you should If you take too much Potassium para-aminobenzoate Powder, or somebody else accidentally swallows Potassium para-aminobenzoate Powder, contact your doctor or the nearest hospital casualty department immediately. Treatment for overdose will depend on the symptoms that are shown. If you forget to take Potassium para-aminobenzoate Powder If you miss a dose, wait until the next time you should take Potassium para-aminobenzoate Powder and take it as normal. Do not take a double dose to make up for a forgotten 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. Stop using Potassium para-aminobenzoate Powder and seek medical attention immediately if you notice any of the following symptoms:
- widespread rash, high body temperature and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms; DRESS syndrome or drug hypersensitivity syndrome).
- allergic reactions, including severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle pain, blisters, oral lesions, swelling of the skin.
- intense hunger, shaking, feeling nervous, anxious or confused, sweating, dizziness or feeling light-headed, sleepiness, difficulty speaking or weakness. These symptoms may be caused by low levels of sugar in your blood (hypoglycaemia). Other possible side effects: Common (may affect up to 1 in 10 people)
- nausea (feeling sick), vomiting (being sick), loss of appetite, stomach discomfort, diarrhoea
- fever, chills Uncommon (may affect up to 1 in 100 people)
- skin rash (including widespread rash, eczema, skin inflammation, chills), itching
- raised levels of liver enzymes (your doctor may arrange for you to have a blood test to check this) Rare (may affect up to 1 in 1,000 people)
- inflammation of the liver (hepatitis) Not known (frequency cannot be estimated from the available data)
- DRESS syndrome or drug hypersensitivity syndrome
- reduced levels of blood sugar (hypoglycaemia)
- drug-induced liver injury and hepatic failure 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 Website: 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 of the safety of this medicine.
How to store it
POTASSIUM PARA-AMINOBENZOATE POWDER Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 25 °C. Store in the original packaging. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Potassium para-aminobenzoate Powder contains The active substance is potassium para-aminobenzoate. Each sachet contains 3 g of the active ingredient. There are no other ingredients. What Potassium para-aminobenzoate Powder looks like and contents of the pack Potassium para-aminobenzoate Powder is a white/off-white powder contained in a foil laminate sachet. Each pack contains 40 sachets. Marketing Authorisation Holder Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom Manufacturer CHEPLAPHARM Arzneimittel GmbH Ziegelhof 23-24 17489 Greifswald For information about this medicine, contact the medical information department via email: [email protected]. Product Licence Number: PL 45043/0044 This leaflet was last revised in September 2022.
Frequently asked questions about Potassium para-aminobenzoate 3 g Powder Sachets
How do I take Potassium para-aminobenzoate 3 g Powder Sachets?
Potassium para-aminobenzoate 3 g Powder Sachets comes as powder containing 3g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Potassium para-aminobenzoate 3 g Powder Sachets?
The active substance in Potassium para-aminobenzoate 3 g Powder Sachets is potassium para-aminobenzoate.
Are there equivalent medicines to Potassium para-aminobenzoate 3 g Powder Sachets?
Medicines with the same active substance, strength and form include: Potaba 3g Powder Sachets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Potassium para-aminobenzoate 3 g Powder Sachets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Potassium para-aminobenzoate 3 g Powder Sachets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: potassium para-aminobenzoate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Potassium para-aminobenzoate 3 g powder is indicated for the treatment of Peyronie's disease and scleroderma in adults.
4.2. Posology and method of administration
Posology
One sachet containing 3 g Potassium para-aminobenzoate powder should be taken orally, four times daily.
Paediatric population
The safety of Potassium para-aminobenzoate 3 g powder in children aged 0 to 18 years has not been established. No data are available.
Method of administration
For oral use.
The contents of one sachet should be dissolved in cold water or fruit juice and taken orally with food.
4.3. Contraindications
- Hypersensitivity to the active substance potassium para-aminobenzoate, para-substituted aromatic amines (e. g. benzocaine, procaine, ethyl parahydroxybenzoate) or to any of the excipients listed in section 6.1.
- Renal insufficiency (GFR < 45 ml/min).
- Hyperkalaemia (each sachet contains 669 mg potassium).
- Potassium para-aminobenzoate 3 g powder should not be given to patients taking sulphonamides as these medicinal products will be inactivated by potassium para- aminobenzoate (see section 4.5).
- Severe liver damage.
4.4. Special warnings and precautions for use
Hypersensitivity reactions
Potassium para-aminobenzoate 3 g powder must be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle pain, blisters, oral lesions, oedema and eosinophilia) and must not be restarted.
Severe cutaneous adverse reactions
Severe cutaneous adverse reactions (SCARs) manifesting as drug reactions with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in association with Potassium para-aminobenzoate 3 g powder treatment. At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.
If signs and symptoms suggestive of this reaction appear, Potassium para-aminobenzoate 3 g powder should be withdrawn immediately.
If the patient has developed DRESS with the use of Potassium para-aminobenzoate 3 g powder, treatment with Potassium para-aminobenzoate 3 g powder must not be restarted in this patient at any time.
Food intake
Treatment with Potassium para-aminobenzoate 3 g powder should be interrupted during periods of low food intake (e.g. during fasting, anorexia, nausea). This is to avoid the possible development of hypoglycaemia. (see section 4.8).
Hyperkalaemia
In patients with impaired renal function or other diseases like diabetes mellitus, cardiovascular diseases, congestive heart failure, hypoaldosteronism and pseudohypoaldosteronism and/or in case of concomitant treatment with medicinal products that can increase the serum potassium level (see section 4.5), Potassium para-aminobenzoate 3 g powder should be used with caution because of the risk of hyperkalaemia.
Before start of treatment with Potassium para-aminobenzoate 3 g powder, an anamnestic survey of pre-existing hyperkalaemia risk factors including an initial serum potassium determination should be performed for all patients. For patients with an increased risk of hyperkalaemia, serum potassium should be measured at least monthly or at closer intervals depending on risk assessment and monitoring requirements due to other risk factors. For patients with an increased initial serum potassium level, the underlying cause should be identified insofar as possible and serum potassium levels should be normalised before start of treatment with Potassium para- aminobenzoate 3 g powder. For these patients, monitoring after start of therapy should also be performed monthly until long-term normal serum potassium levels are established. After that and for all other patients, monitoring is recommended at least quarterly.
Furthermore, serum potassium should be measured promptly for patients who report symptoms possibly indicative of hyperkalaemia such as muscle pain or tightness, flaccid paralysis, weakness, paraesthesia, nausea, vomiting, palpitations, bradycardia or tachypnoea.
Liver dysfunction
Hepatotoxic effects have been observed for Potassium para-aminobenzoate 3 g powder and were reported as hepatitis (various specifications), drug-induced liver injury or (acute) hepatic failure depending on results of diagnostic investigations, time course of drug use and liver disorder and other accompanying symptoms such as nausea, pyrexia, chromaturia or jaundice. For all patients who take Potassium para-aminobenzoate 3 g powder, regular (at least every 4 weeks) liver function tests must be performed (transaminases, gamma-GT, ALP, LDH, bilirubin). If elevated liver function tests or symptoms indicative of a liver disorder are observed, Potassium para- aminobenzoate 3 g powder must be discontinued immediately.
4.5. Interaction with other medicinal products and other forms of interaction
Sulfonamides will be inactivated by Potassium para-aminobenzoate 3 g powder since aminobenzoate is preferentially taken up by bacteria.
Methotrexate is displaced from plasma protein binding by aminobenzoate. Subsequently, plasma levels of methotrexate may increase if administered together with Potassium para- aminobenzoate 3 g powder.
The potassium in Potassium para-aminobenzoate 3 g powder can reduce the effect of concomitant cardiac glycosides.
Potassium levels may further increase with concomitant use of aldosterone antagonists, potassium-sparing diuretics, ACE inhibitors, beta blockers, non-steroidal anti-inflammatory drugs, angiotensin receptor blockers, calcineurin inhibitors, penicillins, pentamidine, ketoconazole, digoxin, heparin, potassium supplements and other medicinal products containing high potassium amounts.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of potassium para-aminobenzoate in pregnant women.
Potassium para-aminobenzoate 3 g powder is not recommended during pregnancy.
Breastfeeding
It is unknown whether potassium para-aminobenzoate/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded.
Fertility
There are no or limited amount of data on the effects of potassium para- aminobenzoate on fertility.
4.7. Effects on ability to drive and use machines
Potassium para-aminobenzoate 3 g powder has no or negligible influence on the ability to drive and use machines. If patients experience confusion, lethargy or weakness they should not drive until such symptoms have fully reversed.
4.8. Undesirable effects
The following convention has been utilised for the classification of undesirable effects:
Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with Potassium para-aminobenzoate 3 g powder treatment.
Immune system disorders
Not known: hypersensitivity reactions, including immunoallergic hepatitis (characterised by fever, rash, oedema, arthralgia/myalgia, elevated liver enzymes) (see section 4.4.)
Metabolism and nutrition disorders
Not known: hypoglycaemia (see section 4.4)
Gastrointestinal disorders
Common: nausea, vomiting, anorexia, stomach discomfort, diarrhoea
Hepatobiliary disorders
Uncommon: elevated liver enzymes (e.g. transaminases, gamma-GT, ALP, LDH)
Rare: hepatitis
Not known: drug-induced liver injury, hepatic failure
Skin and subcutaneous tissue disorders
Uncommon: skin rash (exanthema, eczema, dermatitis, urticaria), pruritus
Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS)
General disorders and administration site conditions
Common: pyrexia, chills
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No particular problems are expected following overdose with Potassium para- aminobenzoate 3 g powder. Symptomatic and supportive therapy should be given as appropriate.
💬 Ask about this leaflet
Ask anything about Potassium para-aminobenzoate 3 g Powder Sachets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.