Acimol

ACIMOL 500 mg film-coated tablets

Important notes (mandatory information)

Acimol 500 mg film-coated tablets. Active ingredient: L-methionine. Areas of application: for acidifying urine with the aim of inhibiting bacterial growth, improving the effect of certain antibiotics (agents against bacterial infections) (e.g. ampicillin, carbenicillin, nalidixic acid, nitrofurans) and preventing the formation of certain urinary stones (kidney stones, ureteric stones that consist of phosphates (struvite, carbonate apatite, brushite)).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Acimol 500 mg film-coated tablets for use in adolescents aged 12 years and over and adults
Active ingredient: L-methionine

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS ACIMOL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ACIMOL?
3. HOW SHOULD ACIMOL BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ACIMOL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ACIMOL AND WHAT IS IT USED FOR?

Acimol is a urinary acidifier. Acimol is used to acidify urine with the aim of inhibiting bacterial growth, improving the effect of certain antibiotics (agents against bacterial infections) (e.g. ampicillin, carbenicillin, nalidixic acid, nitrofurans) and preventing the formation of certain urinary stones (kidney stones, ureteric stones that consist of phosphates (struvite, carbonate apatite, brushite)).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ACIMOL?

Acimol must not be taken:

• if you are allergic to L-methionine or any of the other ingredients of this medicine listed in section 6.
• in the case of homocystinuria (congenital metabolic disorder).
• in the case of uric acid and cystine stone disease (stones that do not contain phosphate).
• in the case of impaired renal function.
• in the case of oxalosis (increased deposition of calcium oxalate crystals in kidney tissue and/or other organs).
• in the case of methionine-adenosyltransferase deficiency (metabolic disorder).
• in the case of metabolic (e.g. renal-tubular) acidosis (blood acidification).
• by infants.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Acimol if any of the following applies to you.

• If you suffer from a liver disease. There is a risk of substances developing that have harmful effects on the brain and nerves.
• If you suffer from a vitamin deficiency (in particular of the vitamins folic acid, vitamin B2, B6 and/or B12. There is a risk of increased "calcification" of blood vessels. Your doctor may recommend that you take additional vitamin supplements.
• If you suffer from an underactive thyroid gland. Your doctor may test your thyroid function before you take Acimol.
• If you have a tendency to excrete increased amounts of calcium in your urine. Your doctor may monitor your mineral balance.
• If you have a tendency to "blood acidification". Your doctor may carry out regular checks of your acid-base balance.

Children

There are no sufficient studies on the use of Acimol in children. Acimol should therefore not be used in children under 12 years of age. Acimol must not be used in infants.

Taking Acimol with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Please talk to your doctor if you are taking any of the following substances:

• Ampicillin/amoxicillin, carbenicillin (antibiotics).
• Sulfonamides, nitrofurantoin, nalidixic acid (antibiotics).
• L-dopa (for the treatment of Parkinson's disease).
• Methotrexate (for autoimmune diseases or leukaemia).
• Colestyramine, nicotinic acid (agents for the treatment of high blood lipids).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. There are no sufficient data on the use of methionine during pregnancy and breast-feeding. If you are pregnant or if you are breast-feeding, you must not take Acimol unless your doctor considers it to be clearly necessary.

Driving and using machines

No special precautions are necessary.

3. HOW SHOULD ACIMOL BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

In general, 1 - 2 film-coated tablets 3 times a day are sufficient. In order to achieve rapid acidification of the urine, it is advisable to start the therapy with 2 film-coated tablets 3 times a day. In special cases and only on doctor's orders, higher doses may be taken. The aim is a urine pH value of less than pH 6. It must be taken into account that the effect of Acimol may not occur until after 5 - 6 days. Ask your doctor or pharmacist about the significance of urine pH or the measurement of urine pH.

Method of administration

The film-coated tablets are taken whole with plenty of liquid (e.g. a large glass of water) before meals.

Duration of use

The duration of use is determined by the doctor and depends solely on the therapeutic necessity.

If you have taken more Acimol than you should

Methionine, the active ingredient in Acimol, is one of the amino acids that the human body cannot produce itself, but which it needs to build proteins. Methionine is naturally present in many foods. Intoxications (overdose symptoms) have not occurred to date.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

Frequency not known (frequency cannot be estimated from the available data):

• Shift in blood pH towards the acidic range (see section 2. "Warnings and precautions").
• Vomiting, nausea and diarrhoea.
• Drowsiness and irritability.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD ACIMOL BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container. The expiry date refers to the last day of the month indicated. Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What one Acimol film-coated tablet contains

The active ingredient is 500 mg L-methionine. The other ingredients are: microcrystalline cellulose, croscarmellose sodium, hypromellose, macrogol 6000, magnesium stearate (Ph.Eur.) [vegetable], poly(ethylacrylate-co-methyl methacrylate)(2:1), highly dispersed silicon dioxide, pregelatinised starch (from maize), talc, titanium dioxide (E 171).

What Acimol looks like and contents of the pack

White, biconvex oblong film-coated tablet with a break notch on both sides. The break notch is only to make it easier to break the tablet for easier swallowing and not to divide it into equal doses; This pack also contains pH test strips (CE 0197). Acimol film-coated tablets are available in original packs of 48 and 96 film-coated tablets.

Pharmaceutical entrepreneur and manufacturer

Dr. Pfleger Arzneimittel GmbH
D-96045 Bamberg
Telephone: 0951/6043-0
Telefax: 0951/604329
E-mail: info@dr-pfleger.de

This package leaflet was last revised in December 2019.

Source: Information from the package leaflet
Status: 01/2022
Active ingredient: L-methionine. Areas of application: for acidifying urine with the aim of inhibiting bacterial growth, improving the effect of certain antibiotics (agents against bacterial infections) (e.g. ampicillin, carbenicillin, nalidixic acid, nitrofurans) and preventing the formation of certain urinary stones (kidney stones, ureteric stones that consist of phosphates (struvite, carbonate apatite, brushite)).